The EarLens™ Contact Hearing Device transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

Device Description

The EarLens™ Contact Hearing Device (CHD) transmits amplified sound to compensate for hearing impairment by direct vibration of the tympanic membrane (eardrum). The EarLens™ CHD is composed of an external Audio Processor, which includes a Behind-the-Ear (BTE) Unit and an Ear Tip, a Tympanic Membrane Transducer (TMT), the EarLens™ Fitting Software (ELF), and a Charger with a Power Adapter. In this device, light is used to wirelessly transmit both signal and power from the Audio Processor to the TMT. The BTE sits behind the outer ear, housing the rechargeable battery, digital signal processor (DSP), microphones and drive electronics. The Ear Tip contains the light emitter and directs the light signal down the ear canal. The TMT resides at the end of the ear canal on the skin around the tympanic membrane. The TMT receives the light signal and converts it into direct vibration of the umbo of the tympanic membrane. The EarLens™ Charger charges two BTEs at the same time when connected to either the wall power adapter or from the internal battery contained in the Charger. The CHD is patientmatched for single patient use. The ELF enables the hearing professional to program the device specific to the patient's hearing needs. The EarLens™ Impression System is provided to the physician to enable the collection of a deep ear canal impression to create patient-matched TMTs for each patient.

AI/ML Overview

The EarLens™ Contact Hearing Device (CHD) has undergone extensive testing to ensure its safety and effectiveness. Both non-clinical (bench) studies and clinical studies were conducted to support its performance and establish acceptance criteria.

The acceptance criteria and reported device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	No cytotoxicity, skin sensitization, or irritation per ISO 10993 standards. Levels of Nickel leaching within safe European standards (EN1811).	All tests passed. No nickel leaching was noted, and traces of oxidation (discoloration) after prolonged wear were contained beneath the parylene coating, posing no safety risk.
Shelf Life/Sterility	Expected service life of 1 year. Device supplied non-sterile.	Expected service life of 1 year demonstrated through mechanical and reliability testing. Device provided non-sterile.
Electromagnetic Compatibility (EMC)	Max signal variation less than 3dB during EMC tests. Immunity to specified levels for home environment (ESD: +/- 8kV contact, +/- 15kV air; Power frequency magnetic fields: 30 A/m; Conducted RF: 3V r.m.s outside ISM, 6V r.m.s in ISM bands; Radiated immunity: 10 V/m 80 MHz - 2.6 GHz). Performance maintained within +/-3dB in close proximity to intentional radiators.	All EMC tests passed with no variation of more than 3dB observed, demonstrating adequate performance. All immunity tests passed at higher test levels, supporting use in the home environment and on aircraft (RTCA DO-160 Section 20 Category T). No degradation of performance in close proximity to intentional radiators.
Software Level of Concern	Minor, with failures unlikely to cause injury. Maximum Equivalent Pressure Output (MEPO) appropriately limited.	Level of Concern identified as Minor, deemed reasonable given MEPO limitations and hardware component selection.
Electrical Testing	Output Limiter Test: Battery current limited to 12mA ± 1mA at 4.2V.	Passed.
	Harmonic Distortion Test: Distortion less than 5%.	Passed.
	Maximum Output Test (MEPO): Average MEPO ≤ 132 dB SPL.	Average MEPO on four temporal bone samples was 127dB SPL. Passed.
Mechanical & Reliability Testing	Ear Tip Pull Test: Withstands 8oz pull force for 1095 cycles.	Passed.
	Ear Tip Bend Test: Withstands 150° bend for 1095 cycles.	Passed.
	Ear Tip Twist Test: Withstands 150° twist for 1095 cycles.	Passed.
	Accelerated Aging Test (TMT): No performance degradation in TMT output and adhesive bond strengths after 1 year simulated aging at 65°C.	Passed.
	Accelerated Aging Test (Ear Tip): Less than 10% degradation in laser output. No degradation in adhesive bond strength when Ear Tip cable subjected to 10N force for 26 cycles after 1 year simulated aging at 75°C.	Passed.
	Maximum Force on Umbo: Maximum force exerted on the Umbo is ≤ 6mN.	Passed.
	Grasping Tab Mechanical Strength: Withstands pull forces of at least 1N.	Passed.
	Umbo Platform Mechanical Strength: Withstands forces of at least 0.25N.	Passed.
MRI Safety	Device must be labeled "MR Unsafe" and patient provided with a card for TMT removal prior to MRI.	Device is labeled "MR Unsafe" and patient card is required.
Clinical Safety (Primary Endpoint)	No decrease in hearing sensitivity of more than 10 dB in PTA4 (500, 1000, 2000, 4000 Hz) after 4 months of device usage.	No decrease in hearing sensitivity of more than 10 dB was observed. No subject exhibited a >10 dB decrease at any frequency.
Clinical Safety (Secondary Endpoint - AEs)	All AEs temporary and resolved without sequelae. No serious device/procedure-related AEs. No overheating of the ear canal.	31 AEs reported in 20 subjects/22 ears. All but one (sensation of fullness, unresolved but effectiveness not impacted) were temporary and resolved. No serious AEs. Ear canal temperature rise < 1°C.
Clinical Safety (TMT Damping)	Minimal and reversible damping of residual hearing when TMT is in place but BTE unactivated. Average PTA damping ≤ 4 dB.	Average PTA damping was 4 dB, immediately reversible upon TMT removal. Maximum damping of 20 dB at a single frequency. Effect remained constant over 4 months.
Clinical Effectiveness (Primary Endpoint)	Statistically significant improvement in mean aided word recognition (NU-6) at 45 dB HL at 30 days post-placement compared to unaided baseline.	Average baseline unaided score was 52%, average aided score was 85%. Improvement was statistically significant (p<0.0001) and clinically meaningful (33% improvement). Gains persisted through 120 days.
Clinical Effectiveness (Secondary Endpoint - Functional Gain)	More than 10 dB functional gain in thresholds over 2000-10000 Hz for the aided condition at 30 days post-placement compared to unaided baseline.	Mean functional gain was 30.5 dB (p<0.0001), with a maximum of 68 dB at 9-10k Hz. Gains persisted through 120 days.
Clinical Effectiveness (Speech in Noise)	Statistically significant benefit from directional microphone.	Directional microphone provided an average of 3.14 dB benefit over unaided baseline (p<0.0001). Omni-directional mode showed a trend toward improvement but not statistically significant benefit.
Clinical Effectiveness (Perceived Benefit - APHAB)	Statistically significant improvement for EarLens™ relative to unaided.	92% of subjects perceived a statistically significant improvement relative to unaided. Global APHAB scores for EarLens™ were essentially the same as subjects' own hearing aids (1% difference).
Clinical Effectiveness (Patient Satisfaction)	Majority of subjects satisfied with reported outcomes (e.g., sound quality, speech in noise, quality of life).	90% satisfied/very satisfied with speech in noise. 80% improved/very much improved in group conversations. 87.5% improved/very much improved in effort for conversations. 90% satisfied/very satisfied with sound quality. 77.5% improved/very much improved in overall quality of life.

Study Information:

2. Sample Size and Data Provenance:

Pivotal Clinical Study: 48 subjects (96 ears). Prospective, single-arm, open-label study. Subjects served as their own controls (unaided vs. aided). Data provenance is not explicitly stated by country, but the inclusion criteria mention "Native speaker of American English," suggesting the study was conducted in the US.
Ear Impression Study: 78 subjects (154 ears). Retrospective or prospective nature not explicitly stated, but implies observation of a procedure. Again, country of origin is not specified but use of American English would suggest a US-based study.
"Roll-in cohort" (Laser Safety): 10 ears (5 subjects). Prospective.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

For the clinical studies (Pivotal and Ear Impression), the nature of the "ground truth" is based on objective audiometric measurements (hearing thresholds, word recognition scores), subjective questionnaires (APHAB, Study Exit Questionnaire), and clinical observations (tympanic membrane images, adverse event reporting, ear canal temperature measurements).
The raw data for these measurements and observations would be collected by trained healthcare professionals (audiologists, ENT physicians, study coordinators).
Tympanic membrane images (n=78 ears) review: Unspecified number of experts or their qualifications for reviewing these images were provided.
Adverse Event reporting: Medical professionals (investigators, clinicians) determined the nature and resolution of AEs. Their specific qualifications (e.g., radiologist with X years of experience) were not detailed, but they would be medical doctors and/or audiologists involved in the clinical study oversight.
Audiometric data: Audiologists performed the audiometric tests, but the number of experts for establishing "ground truth" (e.g., by consensus on diagnoses) is not specified, as it's typically based on established audiometric thresholds.

4. Adjudication Method for the Test Set:

No specific formal adjudication method (e.g., 2+1, 3+1) is described for the clinical study endpoints or safety events. Results were reported based on statistical analyses of aggregated data and clinical observations by the study investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No direct MRMC comparative effectiveness study was mentioned where human readers' performance with and without AI assistance was evaluated. The clinical study compared the device's performance (aided condition) to the unaided condition (subjects essentially serving as their own control). It also made a brief comparison of APHAB scores between the EarLens™ CHD and "subjects' own conventional hearing aids," but this was not a structured MRMC study designed to measure the improvement effect size of human readers with AI vs. without AI assistance. The APHAB comparison showed essentially no clinically significant difference (1%) between the EarLens™ CHD and conventional hearing aids.

6. Standalone (Algorithm Only) Performance:

The device itself is a hearing aid, not an AI-driven diagnostic algorithm. The "performance testing" described in the bench studies (e.g., electrical, mechanical, reliability) assesses the device's physical and functional characteristics in isolation (standalone) from patient interaction or expert interpretation, according to engineering and safety standards.
The "software" component is for fitting and control, not standalone diagnostic or interpretative performance. The clinical study measures the overall system performance (device + patient interaction).

7. Type of Ground Truth Used:

Clinical Studies:
- Safety: Residual hearing function (PTA4 thresholds), adverse event reporting, tympanic membrane images, ear canal temperature measurements.
- Effectiveness: Objective audiometric data (word recognition scores, functional gain/thresholds), subjective patient-reported outcomes (APHAB, Study Exit Questionnaire), speech-in-noise tests (HINT, Quick SIN).
Bench Studies: Established by adherence to national/international standards (e.g., IEC, ISO, ASTM, EN) and internal engineering specifications, using calibrated instruments and measurement techniques.

8. Sample Size for the Training Set:

There's no explicit mention of a "training set" in the context of an Artificial Intelligence (AI) or machine learning model for diagnostic or prognostic purposes, as the EarLens™ CHD is a medical device for hearing amplification rather than an AI diagnostic tool.
The software mentioned (EarLens™ Fitting Software - ELF, and DSP firmware) is for controlling device parameters as programmed by a hearing professional, not for learning from data.
The "design criteria" for the device would have been developed based on general principles of audiology, psychoacoustics, and engineering, likely informed by existing data and research in hearing impairment and hearing aid design.

9. How Ground Truth for Training Set was Established:

Given that this is not an AI/ML-driven diagnostic device with a "training set" in the conventional sense, the concept of "ground truth" for a training set does not directly apply. The device's "training" or development was based on established scientific principles, engineering standards, and the expertise of hearing professionals. The software's "ground truth" is its programmed function to control the device based on clinician input, verified through functional testing against requirements.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR EARLENS™ CONTACT HEARING DEVICE (CHD)

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Tympanic membrane contact hearing aid: A tympanic membrane contact hearing aid is a prescription device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.

NEW REGULATION NUMBER: 874.3315

CLASSIFICATION: CLASS II

PRODUCT CODE: PLK

BACKGROUND

DEVICE NAME: EARLENS™ CONTACT HEARING DEVICE (CHD)

SUBMISSION NUMBER: DEN150002

DATE OF DE NOVO: JANUARY 6, 2015

CONTACT: EARLENS™ CORPORATION 4045A Campbell Avenue MENLO PARK, CA 94025

REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II

INDICATIONS FOR USE

LIMITATIONS

Prescription Use only: Federal (USA) law restricts this device to sale by or on the order of a physician.

Limitations on device use are included in the Instructions for Use as Contraindications. Warnings, and Precautions

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Contraindications

The Patient must not have known or active medical issues that would preclude having a hearing device, including:

an abnormal tympanic membrane (TM) (deemed perforated, inflamed or has a . dimeric or monomeric area, or in any other way abnormal);
an abnormal middle ear or a history of prior middle ear surgery other than . tympanostomy tubes:
an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane;
an anatomical configuration of the external auditory canal that prevents satisfactory ● placement of the Tympanic Membrane Transducer (TMT);
a history of chronic and recurrent ear infections in the past 24 months; ●
a rapidly progressive or fluctuating hearing impairment;
diagnosed with having a compromised immune system which may impact the tissue ● of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.

Warnings

Before using the EarLens™ CHD, read and make sure you understand each of the following safety warnings:

. The EarLens™ Contact Hearing Device is considered MR unsafe. The CHD should be removed prior to an MRI exam or MRI exposure.
. Do not use therapeutic or medical diathermy using electromagnetic radiation (magnetic induction coils or microwave) from the shoulders up with the EarLens™ CHD in place.
. The Behind-the-Ear (BTE) Unit and Ear Tip contain a Class 1 laser product. It is safe to use under normal operating conditions. The Class I laser light is NOT visible. DO NOT look directly into the Laser or aim it directly into your eye. Should the device become damaged, stop using the device and contact your hearing professional.
If you experience discomfort or pain in your ear, contact your ENT physician ● immediately.
. Do not insert foreign objects into the ear, such as O-tips, bobby pins or fingernails. Insertion of foreign objects could result in pain and damage to the ear, damage to the TMT or cause it to operate improperly.
. Contact your hearing professional if you experience discharge from the ear or persistent discomfort or any other problems.
Should the BTE become unusually warm or hot, promptly remove the BTE and . discontinue use. Contact your hearing healthcare professional.

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Precautions

Individuals with known nickel sensitivity/allergy should be informed that the TMT component contains nickel that is coated with a parylene barrier. If an allergic reaction develops, the TMT should be promptly removed.
The EarLens™ CHD is a patient-matched design and intended to be used for a single . patient.
You may shower, bathe or swim with the TMT in place. Ear plugs may be used to prevent water from entering the ears so long as care is taken to not over-insert them. Removing water from your ears may be more difficult with the TMT in place.
. Avoid getting the BTE unit wet, as this may damage the device. Remove the BTE unit prior to showering, swimming, or bathing.
. You may experience a reduction in your hearing levels when the TMT is in place but the BTE is not activated.
. Do not direct streams of liquid (i.e. isopropyl alcohol. hydrogen peroxide. DeBrox) into your ears, as this may cause the TMT to become dislodged or cause damage to the devices.
Failure to oil the ear canal weekly may result in TMT displacement.
If the EarLens™ BTE fails to operate or if it appears damaged, including the presence of battery leakage or swelling, promptly remove the BTE and discontinue use. Contact your hearing professional.
. Electromagnetic fields produced by other electrical equipment such as cell phones. metal detectors microwaves, RFID systems and commercial theft detection systems (also known as electronic article surveillance [EAS]) may interfere with the CHD. In the event that the patient perceives unexpected noise or interference in the presence of these devices, move away from the source to mitigate the potential interference. Remove the BTE and if you have further concerns, contact your hearing healthcare professional.

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The TMT resides at the end of the ear canal on the skin around the tympanic membrane. The TMT receives the light signal and converts it into direct vibration of the umbo of the tympanic

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membrane. The EarLens™ Charger charges two BTEs at the same time when connected to either the wall power adapter or from the internal battery contained in the Charger. The CHD is patientmatched for single patient use. The ELF enables the hearing professional to program the device specific to the patient's hearing needs. The EarLens™ Impression System is provided to the physician to enable the collection of a deep ear canal impression to create patient-matched TMTs for each patient.

Image /page/3/Picture/1 description: This image shows a diagram of the inner ear. The diagram includes labels for the ear tip and TMT. The diagram also shows a BTE hearing aid.

Figure 1: The EarLens™ Contact Hearing Device

Tympanic Membrane Transducer

The Tympanic Membrane Transducer (TMT) is designed to receive light signals from the Ear Tip and convert the light signals into mechanical vibrations of the tympanic membrane (Figure 2). The TMT is matched for each patient and is placed into position by a physician using the Grasping Tab. It is positioned in the ear at the end of the ear canal on the skin around the tympanic membrane. The Bias Springs, the patient-matched Sulcus Platform, and the Chassis stabilize the TMT in the ear canal, enabling the Umbo Platform to remain in contact with the umbo area of the tympanic membrane. The Photodetector captures the light signals and converts the light energy into current, which activates the Microactuator. The Microactuator vibrates the Umbo Platform, which vibrates the umbo of the tympanic membrane, causing sound to be perceived.

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Image /page/4/Figure/0 description: The image shows a device with several labeled components. The components labeled are a photodetector, grasping tab, microactuator, bias spring, chassis, umbo platform, and sulcus platform. The device appears to be a small, possibly medical, device. The device has a gray and white color scheme.

Figure 2: Tympanic Membrane Transducer

The Audio Processor

The Audio Processor consists of the Behind-the-Ear Unit (BTE) and the Ear Tip. The BTE is directly connected to the Ear Tip via the Ear Tube (Figure 3). The BTE is designed to pick up sounds via the microphone, apply signal processing, and transmit the electrical signal via the Ear Tube to the Ear Tip. The BTE can be removed, replaced, and recharged by the patient. The BTE Case contains two microphones, a digital signal processor, light drive electronics, a Program Selection Button, and a rechargeable battery. The battery is recharged by connecting the Charging Ports to the EarLens™ Charger. The Programming Port enables a hearing professional to program the BTE. The Ear Tube connects the BTE case to the

Image /page/4/Figure/4 description: This image is a diagram of an audio processor. The diagram labels the different parts of the audio processor, including the microphones, ear tip, BTE (behind-the-ear), ear tube, and program selection button. The audio processor is a small electronic device that is worn behind the ear and is used to amplify sound for people with hearing loss.

Ear Tip and can be adjusted by a hearing professional. The Ear Tip receives an electrical signal from the BTE and converts this to a light signal using a light emitter. The Ear Tip is a shell with a large opening or vent. The Ear Tip also stabilizes and aims the light emitter at the Photodetector of the TMT.

The EarLens™ Charger

The EarLens™ Charger is designed to recharge the BTEs and act as a storage and travel case. The Charger incorporates Case Wings, BTE Charging Slots, Charging Status LEDs and an AC Adapter Port. When connected to the wall power adapter, the Charger houses and charges either a single BTE or two BTEs simultaneously. If desired, the Charger can be unplugged from the wall and used as a travel case. The Charger incorporates an internal battery, which will charge the BTEs when the Charger is unplugged. An AC wall power adapter is included.

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EarLens™ Fitting Software (ELF)

The EarLens™ Fitting Software (ELF) is used to program the BTE. The ELF enables the hearing professional to calibrate and program the device specific to the patient's needs with up to four programs. In addition to the ELF software, the following devices are required (Figure 4):

. Personal Computer
. HiPro 2 Box with PC communication cable
. Left/Right programming cables for connecting the hearing devices to the HiPro 2

EarLens™ Impression System

Figure 4: EarLens™ Fitting Accessories

Image /page/5/Picture/7 description: The image shows a laptop, a CD, and a device labeled "5x faster". The laptop is black and has a Dell logo on it. The CD is silver and is lying on the laptop's keyboard area. The "5x faster" device is connected to the laptop with several wires.

The EarLens™ Impression System is used by the physician to collect a deep ear canal impression. The impression is used to manufacture the patient-matched components of the EarLens™ CHD. Mineral oil (White Mineral Oil. Food Grade) is used to provide the surface tension forces to keep the TMT in position.

The EarLens™ Impression System includes:

Reusable dispenser .
. Lubricating mineral oil (single patient use)
EarLens™ Impression Material 50 mL dual cartridge (contains enough material for . approximately three impressions)
. Mixing tip with stainless steel extension (single use)
Impression Container (single use)

The EarLens™ Impression System is regulated under 21 CFR Part 874.3300, product code LDG, which is Class I exempt. However, given the risks associated with the deep ear impression procedure, this procedure was assessed to ensure that it can generate reasonably safe and accurate ear impressions that resulted in appropriately fitted EarLens™ CHD device components (TMT and Ear Tip).

SUMMARY OF NONCLINICAL/BENCH STUDIES

Non-clinical/bench studies conducted on the EarLens™ CHD to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized in the sections below.

BIOCOMPATIBILITY / MATERIALS

The EarLens™ CHD contacts the patient's intact skin surfaces and is therefore characterized as a skin surface contacting device. The TMT is categorized as a permanent contact device as the device is intended to be used more than 30 days. The Audio Processor and Charger are categorized as temporary contact devices intended to be used less than 24 hours at a time. In accordance with ISO 10993-1: Biological Evaluation of

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Medical Devices. Part 1: Evaluation and Testing within a Risk Management Process, the following biocompatibility testing was conducted on the EarLens™ CHD. The biocompatibility assessment was deemed adequate.

Component Tested	Test Requirement	Test Results
EarLens™ CHD System(TMT, BTE, Ear Tip) and Charger	MEM elutionCytotoxicity per ISO10993-5	Pass
EarLens™ Ear Tip (soft)		Pass
EarLens™ System(TMT, BTE, Ear Tip)	Tests skin sensitizationper ISO 10993-10	Pass
EarLens™ System(TMT, BTE, Ear Tip)	Tests for irritation perISO 10993-10	Pass

Table 1: Summary of Biocompatibility Test Results for EarLens™ CHD

Furthermore, the EarLens™ TMT was tested for Nickel leaching per the requirements of EN1811, which is a European standard and the levels of Nickel were found to be within the safe levels per the standard. Although no nickel leaching was noted, results of the 14 dav soak test in simulated sweat solution suggest that traces of oxidation (discoloration) may be visible on the TMT surface following prolonged wear. Performance testing indicated that this is not likely to affect the structural integrity of the TMT within the 1 year expected device life. Because the oxidation (discoloration) was contained beneath the parylene coating, this should not pose a safety risk.

SHELF LIFE/STERILITY

The EarLens™ CHD is provided non-sterile. The expected service life of the EarLens™ CHD and all accompanying components of the system is one year, based on the results of the mechanical and reliability testing. The BTE and Ear Tip can be cleaned with a soft cloth. Liquid cleaners should not be used on the BTE as these can damage the device.

ELECTROMAGNETIC COMPATIBILITY TESTING

The requester conducted electromagnetic compatibility testing on the EarLens™ CHD and its respective components and subcomponents, as applicable, to provide a reasonable assurance of safety of the device.

During all the electromagnetic compatibility (EMC) tests, the BTE and light emitting Ear Tip were coupled to a TMT placed in a mold representative of the anatomical shape of the ear. The Ear Tip was placed at a fixed distance from the TMT and optically coupled to it. The BTE was programmed to output a 1000 Hz acoustic tone at a level 3dB below the full scale. The digital representation of the 1000 Hz tone was encoded into light pulses by the laser housed in the Ear Tip and emitted onto the TMT. The audio signal received at the TMT was monitored. During the EMC tests, continuous monitoring of this signal ensured that the laser output remained stable in the presence of external EM fields generated during the testing and that these external EM fields did not induce any energy in the TMT. The acceptance criteria

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for the variation of this signal was selected to be less than 3dB because this represents a typical volume adjustment step size in audio instruments, including common hearing aids. No variation of more than 3dB was observed during the EMC testing, demonstrating adequate EMC performance of the device system.

Emissions and Immunity Testing

EMC for the EarLens™ CHD was tested for both the normal use of the device and the charging operation. The testing was done in accordance with the FDA recognized standard. IEC 60601-1-2 Ed. 3.0. 2007-03-30. Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests. This testing also was conducted at higher compliance limits per the FDA guidance document. Design Considerations for Devices Intended for Home Use, (issued on November 24, 2014), to demonstrate immunity to the following levels for the home environment:

. Electrostatic Discharge (ESD): +/- 8kV contact discharge and +/- 15kV air discharge
Power frequency magnetic fields: 30 A/m at 50 Hz or 60 Hz
. Conducted RF: 3 V r.m.s outside of ISM and amateur radio bands between 0.15 MHz and 80 MHz: 6 V r.m.s in ISM and amateur radio bands between 0.15 MHz and 80 MHz
. Radiated immunity (RF EM fields): 10 V/m 80 MHz - 2.6 GHz

All tests passed at the higher test levels stated above. which supports immunity at these levels and use of the device in the home environment. Furthermore, in order to assess immunity of EarLens™ CHD on board an aircraft, testing was conducted per the requirements of RTCA DO-160 Section 20 (RF Immunity) Category T, Radio Technical Commission for Aeronautics: Radio Frequency Susceptibility - Well Protected Location, with passing results.

Immunity Tests with Intentional Radiators

In addition, the performance of the EarLens™ CHD was tested in close proximity with intentional radiators, such as cell phones and metal detectors (Table 2). The EarLens™ CHD was placed within 5 cm of each intentional radiator individually to simulate user interaction with the equipment. The EarLens™ CHD was rotated to expose all six sides of the device to the intentional radiator. The BTE was programmed to transmit a 1 kHz tone and the level of tone was continuously monitored at the TMT in presence of the intentional radiators. Acceptance level was set such that the audio level at the TMT remained within +/-3dB of the original level when the intentional radiator was not present.

The following equipment was tested with passing results supporting immunity:

. Cell phones (800MHz/1900MHz)
. Wireless 2.4GHz router
. Cordless phones (900MHz/2.4GHz)
CB radio 27MHz
. Family Radio 460MHz

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Microwave oven
Portable radio 150MHz
Land line phone receiver •
. RFID readers
. Metal detectors (pulse induction)
. Electronic article surveillance (EAS) system

Table 2: Description of Intentional Radiators Used for Testing

Item#	Equipment Description	Manufacturer	RF Output Power	OperatingFrequency
1	Wireless BroadbandRouter - Access point		0.083 Watts	2.4 GHz
2	Portable 2-Way Radio		2 Watts	150 MHz -170 MHz
3	Family Radio ServiceBand Walkie Talkie		0.46 Watts	460 MHz
4	Cordless Phone		88 dBuV/m @ 3m	2.4 GHz
5	Citizen Band CB Radio		4 Watts	27 MHz
6	Cordless Phone		88 dBuV/m @ 3m	900 MHz
7	Cell Phone		1.8 Watts (800MHz)1.4 Watts (1900MHz)	800 MHz,1900 MHz
8	Cell Phone		0.7 Watts (800MHz)1.6 Watts (1900MHz)	800 MHz,1900 MHz
9	Microwave Oven		800 Watts	2.4 GHz
10	RFID Tag/ Reader		N/A	125 kHz
11	Land Line PhoneReceiver		N/A	N/A
12	Metal Detector		N/A	7 kHz
13	EAS System	b(4)	N/A	58 kHz
14	EAS System	b(4)	N/A	58 kHz
15	EAS System	b(4)	N/A	58 kHz
16	EAS System	b(4)	N/A	58 kHz

During the immunity testing, no degradation of performance was observed, indicating that the EarLens™ CHD has high immunity against a range of potential interferers that may be encountered in daily use. Higher intensity or different configurations of potential interferers may negatively impact coexistence in ways not observed here. As an added warning, the device labeling (including patient manual) includes the recommendation from IEC60601-1-2:2007 on the minimal distance to avoid different interferers of different frequencies and output levels.

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SOFTWARE

Level of Concern

The requester identified the Level of Concern for the EarLens™ CHD as Minor based on their answers to the questions listed in Table 1 (Major Level of Concern) and Table 2 (Moderate Level of Concern) of the FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Consequently, the requester states that any failure or design flaws in the software are unlikely to cause any injury to the patient or to the (clinician) operator. Given that the device maximum equivalent pressure output (MEPO, discussed below) is appropriately limited based on the device design and the selection and tolerance of the various device hardware components including the BTE (e.g., battery, DSP, and laser diode) and TMT (photodetector and microactuator), this assessment for software risk is reasonable.

Software Description

EarLens™ software is designed in accordance with the guidance of ISO 13485 and ISO 62304, Medical devices -- Quality management systems -- Requirements for regulatory purposes and ISO 62304, Medical device software -- Software life cycle processes, and is very similar to software used in fitting air conduction hearing aids. The fitting software controls the parametric settings of the hearing aid and DSP firmware applies these values in the fitting of the EarLens™ CHD. During the fitting process, clinicians specify the parametric values of the device programs by entering values from their keyboards of the PC. The DSP firmware applies these values by writing these values into the hardware.

The EarLens™ Fitting Software (ELF) is used to program the BTE. The ELF software enables the hearing professional to calibrate and program the device specific to the patient's needs. In addition to the ELF software, the following devices are required:

Personal Computer, Windows 7 platform (details below)
. HI-PRO 2 Box with PC communication cable
. The HI-PRO 2 box [GN Otometrics A/S] is a standard programming interface for many hearing aid systems. It connects to a computer using a USB interface and to the hearing aid using programming cables. The HI-PRO 2 is powered from the USB interface. The HI-PRO 2 has the following additional characteristics:
- Safety: EN 60601-1, Type BF
- . Electromagnetic Compatibility: EN 60601-1-2
- Systems: EN 60601-1-1 or IEC 60601-1, 3rd ed.
- I Hearing Instrument Interface: EN 60118-14
Left/Right programming cables for connecting the EarLens™ BTEs to the HiPro ● 2 via the programming ports. These cables are available from a number of hearing aid industry supplier b(4) ]. The 4 pin CS44 is compatible with the EarLens™ CHD.

CS44 is compatible with the EarLens™ CHD

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The ELF software is stored on a Compact Disc (CD) and is installed using an industry standard installation package and can be run from an icon on the desktop.

Device Software Hazard Analysis

The potential hazard associated with the use of the device is the potential occurrence of uncomfortably loud sounds. The hearing aid may cause momentary discomfort at the time of the occurrence. This hazard is mitigated by limiting the hearing aid output to below the patient's loudness discomfort level.

Software Requirement Specification

The fitting software is used to program the parameters and the DSP firmware applies these values in the hardware. b(4)

Standard PC peripherals include a monitor with 1024x768 resolution, mouse and a keyboard. b(4)

Verification and Validation

The software is verified using functional testing against requirements, unit tests and moreover, the clinical study validates that the compression algorithms functions as designed.

Revision Level History

The software is version controlled and the revision history is maintained. The latest version is 1.0.3.0 and version 1.1.20 for the DSP firmware.

PERFORMANCE TESTING - BENCH

The requester conducted performance testing on the EarLens™ CHD to support a reasonable assurance of safety and effectiveness of the device. All of the testing described below was conducted on final versions of the TMT, BTE, Ear Tips and Chargers (or final subassemblies) which were manufactured in the final form using representative production processes. Appropriate sample sizes were justified. Table 3 provides a summary of each of the bench test purpose, methods, acceptance criteria, and results. In sum, the bench testing was deemed adequate and supports an expected device life of 1 year.

Table 3: Summary of Bench Testing

Test Standard/Method	Test Purpose/Description	Component(s)Tested	AcceptanceCriteria	Results
IEC 60601-1 Standardfor medical electricalequipment: Generalrequirements on basicsafety and essentialperformance	TodemonstratethatEarLens™CHD meetsgeneral safetyrequirements	• TMT• BTE• Ear Tip• Charger	Per thestandardrequirements	All tests Passedand requirementsof IEC 60601-1Edition 3.0, 2005-12 were met.
IEC 60601-1-11Collateral standard formedical electricalequipment and medicalelectrical systems usedin the home healthcareenvironment	TodemonstratethatEarLens™CHD is safeto use in thehomeenvironment	• TMT• BTE• Ear Tip• Charger	Per thestandardrequirements	All tests Passedand requirementsof ANSI/AAMI(IEC) 60601-1-11:2010 were met.
IEC 60825-1Standard for safety oflaser products:equipment classificationand requirements	Todemonstratethat the laserused inEarLens™CHD is safeand classifiedas Class Ilaser product	• BTE• Ear Tip	Per thestandardrequirements	All tests Passedand the output ofthe laser used wasfound to be wellwithin the safeaccessibleemission levels(AEL) andmaximumpermissibleexposure (MPE)levels for eye andskin. EarLens™CHD wasclassified as aClass I laserproduct per theIEC 60825-1.
ASTM D4169Standard practice forperformance testing ofshipping containers andsystems	TodemonstrateEarLens™CHD can bereliablyshipped	• TMT• BTE• Ear Tip• Charger	Per thestandardrequirements	All tests Passedand requirementsof ASTM D4169were met.
Electrical Testing
Output Limiter TestMeasure worst casebattery current and thelaser output	Todemonstratethe outputlimiter limitsthe laseroutput for safe	• BTE• Ear Tip	Batterycurrent islimited to 12mA ± 1 mAat batteryvoltage 4.2V.	Passed
	operation
Harmonic DistortionTestMeasure harmonicdistortion at the BTEoutput with a 1kHz toneat -3dB re FSMeasure harmonicdistortion at the TMToutput with a frequencysweep up to 10,000 Hzat -3dB re FS light input	Todemonstratethe distortionof theEarLensTMCHD is low	• BTE• Ear Tip• TMT	Distortion isless than 5%	Passed
Maximum Output TestMeasure averagemaximum equivalentpressure output (MEPO)in human temporalbones	Todemonstratethat themaximumoutput ofEarLensTMCHD does notexceed 132dBSPL	• BTE• Ear Tip• TMT	Averagemaximumequivalentpressureoutput(MEPO) is$≤$ 132 dB SPL	Passed
Mechanical and Reliability Testing
Ear Tip Pull TestCheck the Ear Tip cableintegrity during andafter repeatedapplication of 8oz. offorce at the connectorend of the cable	To assessreliability ofthe Ear Tip	• Ear Tip	Ear Tip cablewithstands 8oz. of pullforce at theconnector for1095 cycles	Passed
Ear Tip Bend TestCheck the Ear Tip cableintegrity during andafter repeatedapplication of a 150°bend to the cable fromits nominal position at	To assessreliability ofthe Ear Tip	• Ear Tip	Ear Tip cablewithstands150° bendfor 1095cycles	Passed
the point where thecable is expected toenter the ear canal
Ear Tip Twist TestCheck the Ear Tip cableintegrity during andafter repeatedapplication of a 150°twist to the cable fromits nominal position atthe connector to theBTE	To assessreliability ofthe Ear Tip	• Ear Tip	Ear Tip cablewithstands150° twistfor 1095cycles	Passed
Accelerated Aging Test- TMTTest performance ofTMT after 1 year ofsimulated aging at 65°C	To assessreliability ofadhesivebonds andcomponents	• TMT	Noperformancedegradationin TMToutput andadhesivebondstrengths	Passed
Accelerated Aging Test- Ear TipTest performance of EarTip after 1 year ofsimulated aging at 75°C	To assessreliability ofadhesivebonds andcomponents	• Ear Tip	Less than10%degradationin laseroutputNodegradationin adhesivebond strengthwhen Ear Tipcable isrepeatedlysubjected to10N force atthe connectorend for 26cycles	Passed
Maximum force on theUmbo of the eardrumMeasure bias forceexerted by the UmboPlatform of the TMTunder worst caseorientation of the devicewhere effects of gravityare additive	To ensure safeoperation ofTMT	• TMT	Maximumforce exertedon the Umboof theeardrum bythe TMT is ≤6mN	Passed
Mechanical strength –grasping tabApply and measureforce using a forcegauge coupled to thegrasping tab while thechassis is held in fixedposition and increaseforce until componentfailure is observed	To ensuregrasping tabremains intactwith forcesarising frommanipulationby thephysician	• TMT	Grasping tabwillwithstandpull forces ofat least 1N	Passed
Mechanical strength –Umbo PlatformApply and measureforce using a forcegauge coupled to thedrive-post , while theUmbo Platform is heldin fixed position andincrease force untilcomponent failure isobserved	To ensure theumboplatform doesnot separate	• TMT	UmboPlatform willwithstandforces of atleast 0.25N	Passed

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IEC 60601-1 Testing

The EarLens™ CHD was tested per the requirements of IEC 60601-1, Edition 3.0, 2005-12, Standard for medical electrical equipment: General requirements on basic safety and essential performance to provide reasonable assurance of the basic safety and essential performance of the device. These tests included power consumption test, humidity preconditioning, determination of applied parts and accessible parts, durability and legibility of markings test, leakage current test, patient leakage test, dielectric strength test, ball pressure test, creepage distances and air clearances, sharp edges test, instability in transport position test, instability excluding transport test, normal heating test, ingress of liquids,

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hazardous situations and fault conditions test, rigidity of enclosure (push) test, strength of enclosure (impact) test, drop impact, and mold stress relief test. All tests passed.

IEC60601-1-11 Testing

The EarLens™ CHD is expected to be used predominately by an older population (>60 years of age) based on the ages of the study subjects in the clinical studies. It was therefore determined that compliance with IEC 60601-1-11:2010 is necessary. This standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by the manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. Compliance testing to this standard was successfully completed and EarLens™ CHD demonstrated basic safety and essential performance as it pertains to medical equipment in the home healthcare environment following the guidelines of the ANSI/AAMI HA606061-1-11:2010 version of this home healthcare environment standard.

These tests include environmental conditions of transport and storage between uses, environmental operating conditions, shock test for mechanical strength for transit-operable ME equipment, and broad-band random vibration test for mechanical strength for transitoperable ME equipment.

IEC60825-1 Testing

The EarLens™ CHD was tested per the requirements of IEC 60825-1. Safety of Laser Products, and was classified as a Class I laser product. The output of the laser used in the EarLens™ CHD was found to be well within the safe accessible emission levels (AEL) and maximum permissible exposure (MPE) levels for eye and skin.

These tests include measurement of laser radiation and measurement of pulse width and demonstrate safe operation of the laser used in the EarLens™ CHD. Additionally, as part of the clinical study described below, a 'roll-in cohort' of 10 ears (5 subjects) underwent multiple temperature measurements within their ear canal after at least 8 hours of continuous use with the CHD and exposure to the laser. The results showed that there was less than 1°C temperature rise in the ear canal, further demonstrating the safe operation of the laser used in the EarLens™ CHD.

Electrical Testing

Extensive testing was conducted on the EarLens™ CHD to verify the design criteria and device performance with respect to the electrical system specifications and properties in support of its safety and effectiveness. The BTE Audio Processors, Ear Tips and Chargers were tested in finished form and passed the following tests: total harmonic distortion, maximum output, output noise, microphone directionality, programmable settings, dielectric

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strength and leakage current, battery charge time, light output, electromagnetic emissions and immunity. The TMTs were tested in finished form and passed the following tests: total harmonic distortion and vibrational response at -3dB re F.S. and -20dB re F.S. input levels, electromagnetic emissions and immunity.

Mechanical and Reliability Testing

Extensive testing was conducted on the EarLens™ CHD to verify the design criteria and device performance with respect to the mechanical system specifications and properties in support of reasonable assurance of safety and effectiveness.

The BTE Audio Processors, Ear Tips and Chargers were tested in finished form and passed the following tests: operating conditions, storage conditions, Ear Tip pull test, Ear Tip bend test, Ear Tip twist test, accelerated aging test, liquid/dust ingress test, BTE mechanical strength test. BTE dimensional measurements. Ear Tip vent hole dimensional check, BTE connector torque test, and shipping and environmental tests per ASTM D4169-09.

The TMTs were tested in finished form and passed the following tests: TMT dimensional check, TMT mass, TMT bias force test, TMT adhesive bond strength tests, accelerated aging and fatigue test, shipping and environmental tests per ASTM D4169-09. The maximum worst-case force applied to the umbo under normal conditions was measured and determined to be at a safe limit. The information provided is adequate validation of the force applied to the tympanic membrane (< 6mN) using an appropriate model. Accelerated fatigue testing included a finite element analysis of the microactuator reed and a cyclic fatigue analysis of the bias springs to show that the device is likely to maintain its structural integrity and function for at least 1 year of use under worst case conditions. Tensile testing was performed after accelerated aging in order to confirm long term adhesive bond strength.

Temporal Bone Testing

As part of the non-clinical validation, a temporal bone model was used to ensure that the output of the system was within the expected range. In this validation, a calibrated Laser-Doppler Vibrometer (LDV) was used to measure the amplitude of motion of the footplate of the stapes on four temporal bone samples. In each case, the tympanic membrane was exposed to acoustic energy at frequencies between 100Hz and 24,000Hz, and a probe microphone was used to measure the sound pressure level at the tympanic membrane. The sound pressure level and stapes motion were measured simultaneously, and a transfer function determined for each frequency measured (Figure 5a).

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Image /page/17/Picture/0 description: This image shows a diagram of the inner ear. The diagram shows the sound pressure input, the sound pressure measurement via probe tube microphone, and the stapes velocity via laser-Doppler vibrometer (LDV). The sound pressure input is shown as blue waves, the sound pressure measurement is shown as a black line, and the stapes velocity is shown as a red line.

Figure 5a: Stapes Velocity Measurements with an acoustic input

Next, for each temporal bone sample, a CHD system was placed and activated in a normal fashion (see Figure 5b). The stapes motion and CHD output signal were recorded and a second transfer function recorded. The two measurements can be correlated to determine the output at full scale, or Maximum Equivalent Pressure Output (MEPO).

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Image /page/18/Picture/0 description: This image shows a diagram of the inner ear. The diagram shows the light signal driven by the ear tip. The stapes velocity is measured via laser-Doppler vibrometer (LDV).

Figure 5b: Stapes velocity measurement with a vibratory input

In order to determine the equivalent output of the system in a worst case condition, the emitter was positioned so that all of the light energy was focused on the photodetector of the TMT and the MEPO again determined. In addition to the MEPO calculation based on moderate sound pressure levels, the CHD was driven to full scale output for both the nominal and worst case emitter positions. The testing demonstrated that the overall mean maximum equivalent pressure output (MEPO) of the system on four temporal bone samples was 127dB SPL. This is an acceptable maximum equivalent pressure output for the device. The information provided is adequate validation of the output applied to the tympanic membrane in a clinically appropriate model.

Magnetic Resonance Imaging (MRI) Safety

The TMT contains an electromagnetic actuator and ferromagnetic materials that could lead to patient injury or device damage during exposure to a magnetic resonance environment. To mitigate this risk, the device is labeled "MR Unsafe." In addition, a patient card is required to be provided to the patient. which instructs physicians to remove the TMT from the eardrum prior to performing an MRI examination.

SUMMARY OF CLINICAL INFORMATION

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The following is a summary of two clinical studies performed by the sponsor to support a reasonable assurance of safety and effectiveness for the EarLens™ CHD.

Ear Impression Study

EarLens™ conducted an impression study to collect ear impressions from many different ear canal anatomies, which provided validation of the deep canal impression procedure itself. This ear impression procedure involves making a mold deep into the canal and including the tympanic membrane and thus, is considered to involve slightly more risk than typical ear impression procedures for conventional types of hearing aids. The procedure will be performed by a healthcare professional trained in this particular ear impression procedure.

A total of 78 subjects had bilateral ear canal impressions taken (37 female, 41 male). The total number of ears that had impressions taken was 154 (2 subjects had unilateral impressions). Subject age ranged from 32 to 82 years with an average of 66.1 years. The subjects were seen across three clinical sites.

A total of 200 ear impressions were taken on 154 ears (78 subjects). Fourteen subjects (18%) required more than one clinic visit to obtain adequate ear impressions. Multiple impressions were required on some subject ears due to the presence of voids in the impression of anatomical areas that are critical to the patient-matched transducer. The average number of impressions per subject was 2.6, or 1.3 per ear. Thirty-eight percent (38%) of subjects required three or more impressions; 17% required four or more impressions.

Based on a subject survey, a total of 84% of impressions were rated as either no discomfort or mild discomfort. While 80% of the study ears were observed to be normal (unremarkable otoscopic inspection) after the impression procedure, the remaining ears were reported with minor skin contact findings. The most common observation was a micro-hematoma (16%), while petechia (1%), ecchymosis (2%) and abrasion (1%) were reported less frequently. All otologic findings resolved without treatment and without sequelae. Micro-hematomae and ecchymoses can take 2-4 weeks to resolve. Abrasion and petechia, depending on extent and location, can be a more minor finding and may or may not require delay of subsequent otologic procedures, including transducer placement.

Given the nature of this ear impression procedure, the numbers of adverse events reported above are anticipated and acceptable. No major or permanent trauma to the ear canal or tympanic membrane was noted. In order to minimize adverse events, training in this type of ear impression procedure will be necessary and designated as a special control to fit the EarLens™ CHD.

Pivotal Clinical Study

A clinical study of the EarLens™ CHD confirmed a reasonable assurance of safety and effectiveness of the device for individuals with a mild to severe sensorineural hearing impairment between the frequencies of 125 Hz to 10.000 Hz. This prospective, single arm, open label study assessed 48 subjects (96 ears) who wore the fully activated system in both ears in their daily lives for four months per study protocol. The subjects served as their own controls, with outcomes

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comparing the unaided (no treatment) condition to the aided (treatment with the EarLens™ CHD) condition. Safety and effectiveness were assessed during the four months.

The average age of the study population was 69 years with gender ratio at 60% for males and 40% for females. The subjects were seen across three clinical sites with the largest enrollment at Site 1 (Site 1= 21, Site 2=15, Site 3=12). All subjects were experienced hearing aid users who met the inclusion and exclusion criteria.

The inclusion criteria were:

1. Age 18 to 85 years;
1. Mild to severe hearing impairment within the fitting range shown below: One frequency may fall outside range for each ear;

Freq (Hz)	125	250	500	1000	2000	4000	6000	8000	10000
HL min (dB)	0	0	0	0	15	30	30	30	30
HL max (dB)	50	60	60	70	75	80	80	80	80

Image /page/20/Figure/6 description: This image is an audiogram, which is a graph that shows a person's hearing thresholds at different frequencies. The x-axis represents frequency in Hertz (Hz), ranging from 125 to 10k. The y-axis represents hearing level in decibels (dB), ranging from -10 to 100. The shaded area on the audiogram represents the range of sounds that the person can hear, showing a hearing loss at lower frequencies.

1. Symmetric hearing impairment: no more than a 15 dB difference in thresholds between the ears at five of eight tested frequencies (125, 500, 1000, 2000, 4000, 8000, and 10.000 Hz).
1. The difference between the diagnostic word recognition scores (Northwestern Auditory Test No. 6 (NU-6)) between the two ears for a given subject must not exceed 25% to reduce the possibility that a subject may have retrocochlear involvement.
1. No significant conductive hearing impairment;
- a. No more than a 10 dB air-bone gap at three of four tested frequencies (500, 1000, 2000. or 4000 Hz):
- b. Normal Type A tympanometry (indicating normal mobility of the tympanic membrane (TM) and middle ear ossicles).

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1. Greater than or equal to 60% on maximum word recognition score using a 50-word NU-6 list for each ear measured at a presentation level determined by the threshold at 2000 Hz and presented over inserts or earphones demonstrating an ability to benefit from amplification.
1. Current unilateral or bilateral user of hearing aids for at least 6 weeks prior to study enrollment.
1. Able and willing to commit to the travel and time demands of the study (available for six months or longer) and able to comprehend and comply with the study materials and instructions.
1. Native speaker of American English due to use of American English study materials.

The exclusion criteria were:

1. Must not have known or active medical issues that would preclude having the study device, including:
- a. abnormal TM (deemed perforated, inflamed, scelerotic, or has a dimeric or monomeric area, or in any other way abnormal);
- b. Abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes:
- c. Ear canal anatomy that prevents the physician from seeing an adequate amount of the TM, or an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT (examples include a large anterior canal bulge and exostoses of the ear canal).
1. Must not have other known or active medical issues including:
- a. History of chronic and recurrent ear infections in the past 24 months;
- b. History of dizziness and/or vertigo in the past 24 months:
- Currently taking medications/treatments with known ototoxic effects; C.
- d. Rapidly progressive or fluctuating hearing impairment:
- e. Diagnosis of a compromised immune system which may impact the tissue of the auricle or ear canal, keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six months.
1. Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56.
1. Must not have an ear canal anatomy that precludes manufacture of the TMT as determined by EarLens™ manufacturing personnel. The manufacturing personnel will be independent from the personnel evaluating the audiological data.

Safety Results

The primary safety endpoint was intended to demonstrate that use of the EarLens™ CHD did not result in a change in residual hearing function. The objective was to identify any change in baseline hearing after four months of device usage using a four frequency threshold criteria (500, 1000. 2000. and 4000 Hz. referred to as PTA4). A determination of clinically non-significant hearing threshold change was made if the calculated PTA4 hearing change of the subject population was less than 10 dB. After wearing the TMT for 4 months, no decrease in hearing

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sensitivity of more than 10 dB was observed. A secondary safety endpoint assessed any decrease in hearing sensitivity of >10 dB by subject per ear at each test frequency. After four months of use, no subjects exhibited a decrease of >10 dB at either ear by frequency. In addition, no serious device or procedure-related adverse events (AEs) were reported during the trial. There were 31 AEs reported in 20 subjects at 22 ears. All but one of the AEs was temporary and resolved. One subject reported a 'fullness' sensation when wearing the CHD, which did not change during the trial but effectiveness outcomes for this subject were not impacted. The subject continued use throughout the study period of four months. The event is unresolved because the subject elected to participate in the protocol extension and had the devices replaced after the 4-month study period. The following table (Table 4) identifies the AEs by type, frequency of occurrence and resolution status at the active study end.

Adverse Event Category	NumberOccurring	Serious AE	Status
Abrasion/blood blister in earcanal	17	No	Resolved
Ear discomfort/pain	5	No	Resolved
Inflammation/granulation tissueon tympanic membrane	3	No	Resolved
Abrasion/blood blister ontympanic membrane	2	No	Resolved
Ear tip-related:
Ear canal swelling, itching, etc	2	No	Resolved
Pain upon eructation & valsalva	1	No	Resolved
Sensation of fullness	1	No	Ongoing

Table 4: Adverse events across study period
---------------------------------------------	--	--	--	--	--	--

In addition, images of the subjects' tympanic membranes were taken pre- and post-4 months of EarLens™ CHD wear. These images (n=78 ears) were reviewed and were unremarkable. No significant safety concerns were noted.

In order to assess the risk of overheating of the ear canal from the light source transducer (laser diode), 5 roll-in subjects were enrolled in a pilot phase of the study for this safety analysis. Ear canal temperature measures in the 5 roll-in subjects (10 ears) showed no rise in ear canal temperatures after 8 continuous hours of device use. This clinical validation, in conjunction with the non-clinical testing of the laser diode, provides a reasonable assurance of the safety of this component of the EarLens™ CHD.

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Hearing thresholds were measured with the TMTs in place, but without the audio processor, in order to assess the potential temporary tympanic membrane damping that may occur as a result of having a device in continuous contact with the surface of the tympanic membrane. The TMTs are designed to remain in place even when the Audio Processor is not worn. When the audio processor is removed (swimming, bathing, sleeping), users may experience tympanic membrane damping, which would be interpreted as slight reduction of sound that already caused by their hearing loss, due to the loading effect of the TMT. The amount of damping observed varied, but the effect on PTA (500Hz, 1000 Hz, and 2000 Hz) averaged 4 dB of damping, which is immediately reversed when the TMT is removed. The maximum amount of damping observed was 20 dB at a single frequency. The amount of damping stayed essentially the same for the duration of the 4 month study. When the audio processor is in place, the gain delivered by the EarLens™ CHD more than overcomes the TM damping effect. Figure 6 shows the average amount of damping observed across the frequency range 125-10000 Hz (n=90 ears).

Image /page/23/Figure/1 description: The image is a graph that shows hearing change in decibels (dB) as a function of frequency in Hertz (Hz). The x-axis is on a logarithmic scale, ranging from 100 to 100000 Hz. The y-axis represents the hearing change in dB, ranging from -10 to 10. The graph shows a curve that fluctuates between approximately -6 dB and 0.5 dB.

Figure 6: Damping of hearing from presence of TMT compared to unaided baseline

Effectiveness Results

The primary efficacy endpoint was intended to demonstrate device effectiveness by improving speech recognition using the Northwestern Auditory Test No.6 (NU-6) of word recognition with the EarLens™ CHD at a speech level of 45 dB HL. The objective was to show that the EarLens™ CHD provides a statistically significant improvement in mean aided word recognition at 30 days post placement when compared to the baseline unaided condition measured prior to placement. The average baseline unaided score was 52% and the average aided score was 85% (see Figure 7); this improvement was statistically significant (p<0.0001) and very clinically

Frequency (Hz)

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meaningful with an average of 33% improvement in word recognition ability at a soft listening level.

A secondary measure of device effectiveness was defined as more than 10 dB improvement (functional gain) in thresholds over the range of frequencies from 2000 to 10000 Hz for the aided condition measured at 30 days post placement when compared to unaided condition measured prior to placement of the EarLens™ CHD. Mean functional gain was 30.5 dB (p<0.0001). indicating that the EarLens™ CHD was able to deliver significant functional gain (see Figure 8). Functional gain reached a maximum of 68 dB at 9-10k Hz, which is not typically achieved with conventional air-conduction hearing aids.

These primary and secondary measures of device effectiveness were repeated at later time intervals in order to demonstrate stability of the subjects' performance over time. The repeated measures provide evidence that the gains made by 30 days persist through the 120-day interval, suggesting that the EarLens™ CHD remains effective while being worn over time.

The signal processing of the EarLens™ CHD includes algorithms (Wide Dynamic Range Compression (WDRC), Fixed Directional Microphone (DDM), Environmental Noise Reduction (ENR), Dynamic Feedback Cancellation (DFC), Automatic Gain Control Output (AGCO), Sliding Bias, and dual microphone processing) that were worn by subjects throughout the study, and thus were included as part of the effectiveness outcomes and perceived benefit.

Additional effectiveness measures included speech in noise testing with the Hearing in Noise Test (HINT) and Quick SIN. The aided 30-day scores trend toward improvement but statistically significant benefit was not reached on either of these tests in the omni-directional microphone listening mode. When directionality was active, the directional microphone provided an average of 3.14 dB of benefit over the unaided baseline condition. This is a statistically significant (p<0.0001) and clinically meaningful improvement relative to the baseline unaided scores.

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An additional measure of device effectiveness was perceived benefit as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB). The APHAB is a validated and widely used clinical tool for assessing hearing aid benefit. The APHAB was completed for the EarLens™ CHD and the subjects' own conventional hearing aids. The average baseline unaided percentage of communication difficulties was 58% (standard deviation = 16%), the percentage of difficulties decreased to 30% (standard deviation = 13%) with the subject's own air conduction hearing aid, and for EarLens™ it was 29% (standard deviation = 14%). Ninety-two percent (92%) of subjects completing the study (35 out of 38) perceived a statistically significant improvement for EarLens™ relative to unaided as measured by APHAB. based on normative data for this questionnaire.' This amount of benefit is predictive of noticeable benefit and success with amplification. ' The global APHAB scores for the subjects (n=36) using their own hearing aids and the EarLens™ CHD were essentially the same (1% difference) suggesting that there was not a clinically significant difference in perception of overall benefit for the EarLens™ CHD compared to the subjects' own hearing aids as measured by APHAB.

All subjects completed a Study Exit Questionnaire (developed by EarLens™) upon exiting the study after 4 months of EarLens™ CHD wear. This is a 15 item questionnaire that asks subjects to rate their satisfaction with the EarLens™ CHD in the following domains: quality, naturalness, and clarity of sound, understanding speech in noise, ability of the device to address their hearing problems, quality of music, device comfort, cosmetics, etc. For these items, subjects were asked to select one of 6 ratings that ranged from Very Satisfied to Very Dissatisfied. In addition, the subjects were asked to rate the performance of the EarLens™ CHD in terms of how well it improved their experience in several areas (e.g., hearing in noisy environments, ability to participate in group conversations) relative to the unaided condition. Subjects were asked to select one of 5 ratings that ranged from Verv Much Improved to Worse. The majority of subjects were satisfied with their ability to understand speech in noisy environments with the EarLens™ CHD (90% responded Satisfied or Very Satisfied) and found that the EarLens™ CHD improved their ability to participate in group conversations (80% responded Improved or Very Much Improved). Additionally, most subjects found that the EarLens™ CHD reduced the level of effort required to carry on conversations (87.5% responded Improved or Very Much Improved). Overall, most subjects were satisfied with the quality of sound delivered by the EarLens™ CHD (90% responded Satisfied or Very Satisfied) and found that EarLens™ CHD improved their overall quality of life (77.5% responded Improved or Very Much Improved).

'Cox, R., & Alexander, G. (1995). The abbreviated profile of hearing aid benefit. Ear and Hearing, 16(2), 176-186.

Summary of Extended Study

The safety and effectiveness of the EarLens™ CHD is currently being monitored beyond the 4 months of the Definitive Study. In the Extended Study, 24 subjects (48 ears) have opted to continue wearing the device after completing the Definitive study. As of April 30, 2015, 92% of ears have 6 or more months cumulative TMT wear, 50% have 9 or more months, and 4% (2 ears) have 12 or more months of cumulative TMT wear. Of the 24 active subjects in the Extended Wear Study, 11 related AEs were experienced by 8 subjects in 10 ears. All events were temporary and resolved. Nine of 11 AEs were related to ear cleaning pre-impression (3 AEs), the

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impression procedure (4 AEs), or the inspection process pre-impression (2 AE). Two of the related AEs were attributed to Ear Tip fit and both were resolved after Ear Tip modification. One subject continues to report a sensation of fullness.

Based on the results of these clinical studies, the EarLens™ CHD has been shown to be reasonably safe and effective in delivering the full spectrum of amplification from 125 Hz to 10.000 Hz for at least 4 months of wear.

LABELING

The sponsor provided labeling information, which includes Physician Instructions for Use, Patient Instructions for Use, and Hearing Professional Instructions for Use. In addition, the sponsor provides an Ear Impression Kit that includes instructions for the physician regarding how to obtain an ear impression for the EarLens™ CHD. Because the TMT component cannot be self-removed, a patient card is required that can be carried with the patient to provide information about the device (e.g., MR Unsafe, who should remove it, who to contact) in cases of emergency.

The labeling is sufficient and satisfies the requirements of 21 CFR 801.109 Prescription devices. The patient labeling also follows the principles identified in FDA's guidance entitled "Medical Device Patient Labeling" (April 2001). The labeling includes a summary of the clinical studies, detailed instructions on how to fit the device to the patient, instructions for periodic cleaning of the BTE and Ear Tip, and information related to electromagnetic compatibility. In addition, the patient instructions for use includes information on how to correctly use and maintain the device. the potential risks and benefits associated with the use of the device, and alternative treatments.

RISKS TO HEALTH

Table 5 below identifies the risks to health that may be associated with use of tympanic membrane contact hearing aid and the measures necessary to mitigate these risks.

Identified Risk	Mitigation Method
Adverse Tissue Reactions	Biocompatibility Labeling
Electromagnetic Incompatibility	Non-Clinical Performance Testing Labeling
MRI Incompatibility	Labeling
Overheating of Ear Canal or Skin	Non-Clinical Performance Testing Clinical Performance Testing Labeling
Damage to Eyes from Direct Laser Exposure	Labeling

Table 5: Identified Risks to Health and Mitigation Methods

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Trauma/Damage to the Ear Canal, TympanicMembrane, or Middle Ear System	• Non-Clinical Performance Testing• Clinical Performance Testing• Training• Labeling
Residual Hearing Loss	• Non-Clinical Performance Testing• Clinical Performance Testing• Labeling
Ear Infections	• Clinical Performance Testing• Labeling
Vertigo or Tinnitus	• Clinical Performance Testing• Labeling
Dampening of Residual Hearing When theDevice Is Turned off	• Clinical Performance Testing• Labeling

SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the tympanic membrane contact hearing aid is subject to the following special controls:

1. The patient contacting components must be demonstrated to be biocompatible.
1. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include:
- (A) Mechanical integrity testing.
- (B) Electrical and thermal safety testing.
- (C) Software verification, validation, and hazard analysis.
- (D) Reliability testing consistent with expected device life.
- (E) Electromagnetic compatibility testing.
- (F) Validation testing of device output and mechanical forced applied to the tympanic membrane in a clinically appropriate model.
1. Clinical performance testing must characterize any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
1. Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device.
1. Labeling must include the following:
- (A) A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing.
- (B) Detailed instructions on how to fit the device to the patient.

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(C) Instructions for periodic cleaning of any reusable components.
(D) Information related to electromagnetic compatibility.
(E) Patient labeling that includes:
- (i) A patient card that identifies if a patient has been fitted with any non-selfremovable components of the device and provides relevant information in cases of emergency.
- (ii) Information on how to correctly use and maintain the device.
- (iii) The potential risks and benefits associated with the use of the device.
- (iv) Alternative treatments.

BENEFIT/RISK DETERMINATION

The risks of the device are based on data collected in the clinical studies described above. The most commonly occurring adverse events were abrasions, swelling, or blood blisters in the ear canal or on the tympanic membrane (22 occurrences), and were mostly related to the ear impression procedure or insertion/removal of the Ear Tip. The risk of granulation tissue forming on the tympanic membrane was found to be minimal, with only 3 occurrences noted, and images of the tympanic membranes post-EarLens™ CHD removal use suggest that they appear healthy after 4 months of device use. The type and severity of risks associated with the EarLens™ CHD were found to be generally consistent with deep canal hearing aids. Additionally, none of the device-related adverse events reported in the clinical study were determined to be serious in nature, and there were no unanticipated adverse device effects reported. All but one of the reported adverse events was temporary in nature or resolved with minimal to no medical intervention. Unaided hearing thresholds remained stable when compared before and after 4 months of device use. There was no clinically or statistically significant decrease (p < 0.0001) in hearing sensitivity (equal to or greater than 10 dB) at any frequency for the subjects, on average, nor did any single subject experience a 10 dB or greater decrease in hearing at any frequency over the course of the study. Furthermore, damping of the tympanic membrane with the TMT in place was minimal and shown to be completely reversible once the TMT was removed. This strongly supports the safety of the device related to the risk of a decrease in hearing sensitivity as a function of device use. No overheating of the ear canal was observed with the use of the laser diode transducer. Given that this device will be prescribed and monitored by a physician, there is a high likelihood that risks are mitigated and patients would typically experience only nonserious adverse events. which would be reversible by modification or removal of the device.

The probable benefits of the device are also based on data collected in the clinical studies as described above. The measured clinical benefits for these hearing impaired subjects are highlighted in the primary and secondary endpoints and served to show the device's impact on patient communication (i.e., improvement in patient function), patient satisfaction and overall improved quality of life within the target population of individuals 18 years of age and older. The EarLens™ CHD is able to provide significant and appropriate amounts of amplification for patients with mild to severe sensorineural hearing loss, especially in the high frequencies. Substantial improvements in aided thresholds (functional gain) were achieved with the EarLens™ CHD compared to the unaided levels (30.5 dB of functional gain from 2000-10000 Hz on average). Adequate amplification of this frequency region is important for audibility of speech. For some patients, this benefit in magnitude was exceptionally strong in the extended

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high frequency range (8000-10000 Hz) resulting in the benefit of increased audibility across a broad spectrum of sound. It is noted that subjects' performance with the EarLens™ CHD was only compared to without the EarLens™ CHD (unaided hearing loss) on these endpoints, and not to performance with other hearing aids. Thus, we cannot determine if there are any perceptual benefits of the EarLens™ CHD compared to the alternative treatment of conventional air conduction hearing aids for this population. The amplification provided by the EarLens™ CHD resulted in a very meaningful word recognition improvement of ~33% compared to without the device when listening at soft conversational levels (primary endpoint). This is a significant improvement and is expected to yield great benefit for hearing impaired patients in daily communication. This was reflected in an additional measure of subjective benefit on a validated scale used widely in clinical practice to document the benefit of hearing aid fittings: The Abbreviated Profile of Hearing Aid Benefit (APHAB). Subjects showed statistically and clinically significant subjective improvement in ease of communication and listening in noisv environments. An exit questionnaire showed that 90% of subjects were satisfied or very satisfied with the EarLens™ CHD.

In conclusion, given the available information above, the data support that the probable benefits outweigh the probable risks for the EarLens™ Contact Hearing Device for providing amplification of a broad range of frequencies to compensate for mild to severe sensorineural hearing loss in patients 18 years and older. The device provides substantial benefits and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The de novo for the EarLens™ Contact Hearing Device is granted and the device is classified under the following:

Product Code: PLK Device Type: Tympanic membrane contact hearing aid Class: II Regulation: 21 CFR 874.3315

Regulation Number and Section

§ 874.3315 Tympanic membrane contact hearing aid.

(a)
Identification. A tympanic membrane contact hearing aid is a prescription wearable device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. A tympanic membrane contact hearing aid is subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include:
(i) Mechanical integrity testing;
(ii) Electrical and thermal safety testing;
(iii) Software verification, validation, and hazard analysis;
(iv) Reliability testing consistent with expected device life;
(v) Electromagnetic compatibility testing; and
(vi) Validation testing of device output and mechanical force applied to the tympanic membrane in a clinically appropriate model.
(3) Clinical performance testing must characterize any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
(4) Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device.
(5) Labeling must include the following:
(i) A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing;
(ii) Detailed instructions on how to fit the device to the patient;
(iii) Instructions for periodic cleaning of any reusable components;
(iv) Information related to electromagnetic compatibility; and
(v) Patient labeling that includes:
(A) A patient card that identifies if a patient has been fitted with any non-self- removable components of the device and provides relevant information in cases of emergency;
(B) Information on how to correctly use and maintain the device;
(C) The potential risks and benefits associated with the use of the device; and
(D) Alternative treatments.