Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a hearing device utilizing a digital signal processor (DSP) for sound amplification and processing, but there is no mention of AI or ML technologies being used for this processing or any other function of the device.

Therapeutic

Yes
The device is indicated for individuals with hearing impairment and aims to transmit amplified sound to compensate for this impairment, which is a therapeutic function.

Diagnostic

No

The device is described as a "Contact Hearing Device" that "transmits amplified sound to compensate for hearing impairment." Its purpose is to improve hearing for individuals with hearing loss, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including an external Audio Processor (BTE Unit and Ear Tip), a Tympanic Membrane Transducer (TMT), and a Charger with a Power Adapter. While it includes software (ELF), it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the EarLens™ Contact Hearing Device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The EarLens™ device works by directly vibrating the eardrum to transmit sound. It does not analyze any biological samples like blood, urine, or tissue.
The intended use is for hearing impairment. The device is designed to compensate for hearing loss by amplifying sound, not to diagnose a disease or condition through the analysis of a specimen.
The device description focuses on sound transmission and mechanical vibration. The components described (Audio Processor, TMT, etc.) are all related to the process of receiving, processing, and transmitting sound to the eardrum.

Therefore, the EarLens™ Contact Hearing Device falls under the category of a hearing aid or a similar type of medical device used for treatment or compensation of a physical impairment, rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

PLK

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 (Figure 1). 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 patient-matched 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tympanic membrane (eardrum), ear canal, middle ear, umbo

Indicated Patient Age Range

18 years and older

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Ear Impression Study

Study Type: Impression Study
Sample Size: 78 subjects (154 ears total, 2 subjects had unilateral impressions)
Data Source: Clinical sites
Key results: 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. 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. 84% of impressions were rated as either no discomfort or mild discomfort. 80% of the study ears were observed to be normal (unremarkable otoscopic inspection) after the impression procedure. The remaining ears reported minor skin contact findings, most common was micro-hematoma (16%), while petechia (1%), ecchymosis (2%), and abrasion (1%) were less frequent. All otologic findings resolved without treatment and without sequelae. No major or permanent trauma to the ear canal or tympanic membrane was noted.

Pivotal Clinical Study

Study Type: Prospective, single arm, open label study
Sample Size: 48 subjects (96 ears)
Data Source: Three clinical sites
Key results: After wearing the TMT for 4 months, no decrease in hearing sensitivity of more than 10 dB was observed. No subjects exhibited a decrease of >10 dB by frequency after 4 months. No serious device or procedure-related adverse events (AEs) were reported. 31 AEs were reported in 20 subjects at 22 ears; all but one were temporary and resolved. One subject reported a 'fullness' sensation that did not change during trial but effectiveness outcomes were not impacted. Images of tympanic membranes pre- and post-4 months were unremarkable. Ear canal temperatures in 5 roll-in subjects (10 ears) showed no rise after 8 continuous hours of device use. The average baseline unaided scores for word recognition was 52% and average aided score was 85%, which was statistically significant (p

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.

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

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.

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

1

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 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 (Figure 1). 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

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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

6

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 elution
Cytotoxicity per ISO
10993-5	Pass
EarLens™ Ear Tip (soft)		Pass
EarLens™ System
(TMT, BTE, Ear Tip)	Tests skin sensitization
per ISO 10993-10	Pass
EarLens™ System
(TMT, BTE, Ear Tip)	Tests for irritation per
ISO 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 | Model | Serial number | RF Output Power | Operating

Frequency |
|-----------|---------------------------------------------|--------------|-------|---------------|-------------------------------------------|------------------------|
| 1 | Wireless Broadband
Router - Access point | | | | 0.083 Watts | 2.4 GHz |
| 2 | Portable 2-Way Radio | | | | 2 Watts | 150 MHz -
170 MHz |
| 3 | Family Radio Service
Band 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 Phone
Receiver | | | | 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 | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 Standard
for medical electrical
equipment: General
requirements on basic
safety and essential
performance | To
demonstrate
that
EarLens™
CHD meets
general safety
requirements | • TMT
• BTE
• Ear Tip
• Charger | Per the
standard
requirements | All tests Passed
and requirements
of IEC 60601-1
Edition 3.0, 2005-
12 were met. |
| IEC 60601-1-11
Collateral standard for
medical electrical
equipment and medical
electrical systems used
in the home healthcare
environment | To
demonstrate
that
EarLens™
CHD is safe
to use in the
home
environment | • TMT
• BTE
• Ear Tip
• Charger | Per the
standard
requirements | All tests Passed
and requirements
of ANSI/AAMI
(IEC) 60601-1-
11:2010 were met. |
| IEC 60825-1
Standard for safety of
laser products:
equipment classification
and requirements | To
demonstrate
that the laser
used in
EarLens™
CHD is safe
and classified
as Class I
laser product | • BTE
• Ear Tip | Per the
standard
requirements | All tests Passed
and the output of
the laser used was
found to be well
within the safe
accessible
emission levels
(AEL) and
maximum
permissible
exposure (MPE)
levels for eye and
skin. EarLens™
CHD was
classified as a
Class I laser
product per the
IEC 60825-1. |
| ASTM D4169
Standard practice for
performance testing of
shipping containers and
systems | To
demonstrate
EarLens™
CHD can be
reliably
shipped | • TMT
• BTE
• Ear Tip
• Charger | Per the
standard
requirements | All tests Passed
and requirements
of ASTM D4169
were met. |
| Electrical Testing | | | | |
| Output Limiter Test

Measure worst case
battery current and the
laser output | To
demonstrate
the output
limiter limits
the laser
output for safe | • BTE
• Ear Tip | Battery
current is
limited to 12
mA ± 1 mA
at battery
voltage 4.2V. | Passed |
| | operation | | | |
| Harmonic Distortion
Test
Measure harmonic
distortion at the BTE
output with a 1kHz tone
at -3dB re FS
Measure harmonic
distortion at the TMT
output with a frequency
sweep up to 10,000 Hz
at -3dB re FS light input | To
demonstrate
the distortion
of the
EarLensTM
CHD is low | • BTE
• Ear Tip
• TMT | Distortion is
less than 5% | Passed |
| Maximum Output Test
Measure average
maximum equivalent
pressure output (MEPO)
in human temporal
bones | To
demonstrate
that the
maximum
output of
EarLensTM
CHD does not
exceed 132dB
SPL | • BTE
• Ear Tip
• TMT | Average
maximum
equivalent
pressure
output
(MEPO) is
$≤$ 132 dB SPL | Passed |
| Mechanical and Reliability Testing | | | | |
| Ear Tip Pull Test
Check the Ear Tip cable
integrity during and
after repeated
application of 8oz. of
force at the connector
end of the cable | To assess
reliability of
the Ear Tip | • Ear Tip | Ear Tip cable
withstands 8
oz. of pull
force at the
connector for
1095 cycles | Passed |
| Ear Tip Bend Test
Check the Ear Tip cable
integrity during and
after repeated
application of a 150°
bend to the cable from
its nominal position at | To assess
reliability of
the Ear Tip | • Ear Tip | Ear Tip cable
withstands
150° bend
for 1095
cycles | Passed |
| the point where the
cable is expected to
enter the ear canal | | | | |
| Ear Tip Twist Test
Check the Ear Tip cable
integrity during and
after repeated
application of a 150°
twist to the cable from
its nominal position at
the connector to the
BTE | To assess
reliability of
the Ear Tip | • Ear Tip | Ear Tip cable
withstands
150° twist
for 1095
cycles | Passed |
| Accelerated Aging Test

TMT
Test performance of
TMT after 1 year of
simulated aging at 65°C | To assess
reliability of
adhesive
bonds and
components | • TMT | No
performance
degradation
in TMT
output and
adhesive
bond
strengths | Passed |
| Accelerated Aging Test
Ear Tip
Test performance of Ear
Tip after 1 year of
simulated aging at 75°C | To assess
reliability of
adhesive
bonds and
components | • Ear Tip | Less than
10%
degradation
in laser
output

No
degradation
in adhesive
bond strength
when Ear Tip
cable is
repeatedly
subjected to
10N force at
the connector
end for 26
cycles | Passed |
| Maximum force on the
Umbo of the eardrum
Measure bias force
exerted by the Umbo
Platform of the TMT
under worst case
orientation of the device
where effects of gravity
are additive | To ensure safe
operation of
TMT | • TMT | Maximum
force exerted
on the Umbo
of the
eardrum by
the TMT is ≤
6mN | Passed |
| Mechanical strength –
grasping tab
Apply and measure
force using a force
gauge coupled to the
grasping tab while the
chassis is held in fixed
position and increase
force until component
failure is observed | To ensure
grasping tab
remains intact
with forces
arising from
manipulation
by the
physician | • TMT | Grasping tab
will
withstand
pull forces of
at least 1N | Passed |
| Mechanical strength –
Umbo Platform
Apply and measure
force using a force
gauge coupled to the
drive-post , while the
Umbo Platform is held
in fixed position and
increase force until
component failure is
observed | To ensure the
umbo
platform does
not separate | • TMT | Umbo
Platform will
withstand
forces of at
least 0.25N | Passed |

11

12

13

14

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,

15

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

16

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 (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 | Number
Occurring | Serious AE | Status |
|---------------------------------------------------------|---------------------|------------|----------|
| Abrasion/blood blister in ear
canal | 17 | No | Resolved |
| Ear discomfort/pain | 5 | No | Resolved |
| Inflammation/granulation tissue
on tympanic membrane | 3 | No | Resolved |
| Abrasion/blood blister on
tympanic 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.

23

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