The Lumen® 155-SF self-fitting, wireless air conduction hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. The device is intended for over-the-counter sales without the assistance of a hearing health care professional.

Device Description

Per 21 CFR 874.3325 a self-fitting wireless air conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are class II medical devices.

The Lumen 155-SF self-fitting hearing aid(s) with Sentibo application is a self-fitting wireless air conduction Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software to be used on an Apple mobile device (mobile device not included) including wired lightning connector Apple EarPods for the assessment (not included) designed for a single user. The Sentibo app is available only on iOS. The Lumen 155-SF self-fitting OTC hearing aid(s) with Sentibo application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/open dome. The hearing aids can be fine-tuned by the user or remotely at the request of the user via the use of QR codes. Once the hearing aids are switched on, the software (Sentibo app) is required for the initial set-up, which is done via the smart phone and requires Apple EarPods with lightning connector to complete (not included). The Sentibo self-fitting software allows the consumer to self-select a hearing profile from a list of options by listening to digitized speech embedded in the software while scrolling through the hearing profiles in real-time through the Apple EarPods. After the setting is selected, the settings can be transferred from the smart phone to the hearing aid directly, though direct audio streaming from the smart phone to the hearing aid is unsupported with the Lumen 155-SF firmware. All Sentibo settings are stored in the application itself, and no internet service is required to perform the self-fitting. The Sentibo application provides 24 predefined options. At the conclusion of the assessment, the software will program hearing aids wirelessly and the user will wear the hearing aids per normal use. The smartphone app will function as a software accessory, allowing the user to make minor adjustments to the hearing aids. The hearing aid is intended to be used with the Sentibo App and to be worn and removed daily by the end user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance (Lumen 155-SF)	Predicate/Reference Performance	Discussion of Differences & Meeting Criteria
Intended Use	Amplifies sound for adults 18+ with perceived mild to moderate hearing impairment; user-adjusted; OTC sales without hearing health professional assistance.	Meets this exact indication.	Predicate (Nuheara IQbuds 2 PRO) and Reference (Bose SoundControl) have similar intended uses.	Lumen 155-SF's intended use is substantially equivalent to the predicate and reference devices. Minor wording changes in the intended use statement are considered redundant in context of a self-fitting hearing aid.
Electro-Acoustic Characteristics (ANSI/ASA S3.22 & ANSI/CTA 2051)	Latency ≤ 15 ms	5.8 ms	Predicate: 5 ms; Reference: 5.5 ms	Meets criteria of being ≤ 15 ms. Within measurement uncertainty tolerance of predicate/reference.
	Frequency Response	< 200 Hz - 8000 Hz	Predicate: 200 Hz - 8000 Hz; Reference: < 200 - 8000 Hz	Meets the requirements, same as the predicate and reference.
	Input Distortion (clause 4.4.2) ≤ 5%	1.2%	Predicate: 0.7%; Reference: ≤ 5%	Meets the requirements, same as the predicate.
	Equivalent Input Noise (EIN) (Self-generated Noise Levels) (Clause 6.12)	26.4 dB SPL	Predicate: 28.5 dB SPL; Reference: < 23 dB SPL typical, < 27 dB SPL max	Meets the requirements, same as the predicate.
	Harmonic Distortion (Clause 6.11) ≤ 1% max	< 0.5% typical, < 1% max	Predicate: 0.2%; Reference: < 0.5% typical, < 1% max	Meets the requirements, same as the predicate. Minor differences due to physical embodiment do not affect meeting electroacoustic requirements.
	Max OSPL90 (Clause 6.2) ≤ 117 dB SPL	114.4 dB SPL	Predicate: 109.6 dB SPL; Reference: 113 dB SPL	Meets the requirements, same as the predicate. All are < 117 dB SPL limit.
	HFA OSPL90 (Clause 6.3)	109.6 dB SPL	Predicate: 100.9 dB SPL; Reference: 106 dB SPL	Meets the requirements, same as the predicate.
	HFA FOG (Clause 6.5)	51 dB	Predicate: 29.4 dB SPL; Reference: 30 dB	Higher than predicate/reference but device features output limiting always enabled. No different safety/efficacy questions introduced.
	Reference Test Gain (RTG) (Clause 6.7)	45 dB	Predicate: 24.4 dB SPL; Reference: 29 dB	Meets the requirements, same as the predicate. RTG is descriptive only, differences do not introduce different safety/efficacy questions.
Biocompatibility	Conformity to ISO 10993-1, -5, -10, -12	Biocompatible; requirements met. Testing for cytotoxicity, sensitization, intracutaneous reactivity passed.	Not explicitly detailed for predicate/reference, but consistency with them is stated.	Materials used present no biological risk, meeting ISO standards.
Electrical Safety, EMC, Battery Safety	Conformity to IEC 60118-13 (EMC), BS EN 60601-2-66 (Basic Safety & Essential Performance), IEC 60601-1-2 (EMC), IEC 60601-1-11 (Vibration & Shock), FCC & RED Tests (Wireless), AAMI TIR69 (Wireless Coexistence Risk Analysis), IEEE / ANSI C63.27 (Wireless Coexistence), ANSI C63.19 (RF Immunity)	Passed all relevant tests for these standards.	Similar consistency with predicate/reference is stated.	All non-clinical performance testing passed, demonstrating risk mitigation to an acceptable level and reasonable assurance of safe and effective performance.
Software Verification & Validation	Software V&V must be performed.	Performed.	Same standards as predicate.	Software V&V performed per the same standards as the predicate, providing reasonable assurance of safety and effectiveness.
Usability Testing / Human Factors	Demonstrated usability by intended user in accordance with intended use, with adequate mitigations for training and labeling.	Human factors study demonstrated that usability was analyzed, verified, and validated; implemented mitigations for training and labeling are adequate.	Referenced qualitative usability of predicate/reference.	The study provided evidence that the device was safe and effective to operate by the intended user.
Clinical Performance (Non-inferiority)	Non-inferiority of satisfaction outcomes for self-fit vs. professional-fit. Similar levels of perceived benefit and quality of hearing. Measured sound pressure levels at the ear canal quantitatively confirmed safety and efficacy.	Self-fit and Pro-fit groups yielded similar levels of satisfaction with sound quality and fitting process. SSQ-12 and APHAB scores showed similar levels of perceived benefit. Overall Maximum Output SPL was 101.3 dB SPL (safe). Measured results in-situ minus NAL-NL2 targets were similar for both groups.	Reference device (Bose De Novo DEN180026) and Bose SoundControl (K211008) studies used similar assessment approaches.	The clinical study demonstrated non-inferiority to professional fitting and substantial equivalence to predicate/reference based on subjective and objective performance outcomes.

Study Details

A table of acceptance criteria and the reported device performance: See table above.
Sample size used for the test set and the data provenance:
- Clinical Performance Study: 93 adults were initially enrolled, with 92 participants providing data for analysis (45 Self-Fit, 47 Pro-Fit).
  - Provenance: Prospective, multicenter, randomized, single-blind, parallel-arm study. The study was conducted adhere to COVID-19 social distancing needs. The text does not explicitly state the country of origin, but the submission is to the U.S. FDA suggesting a U.S. based or internationally recognized standard study.
- Usability Testing (Human Factors Study): 15 adults (18 years and older) with perceived mild to moderate hearing loss.
  - Provenance: Formative and Summative Evaluations conducted in a one-on-one quiet, comfortable room. No country of origin specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Clinical Performance Study: The "Pro-fit" arm served as a comparative ground truth, where licensed professionals (audiologists, as implied by the context of "licensed professional-fit" using "commercially available fitting software") fitted the hearing aids. The text doesn't specify the number of individual audiologists or their years of experience but indicates they used "best practice fitting algorithms" and were "licensed."
- Usability Testing: An "independent, trained moderator" conducted each session. A "cross-functional team" reviewed outcomes, but their direct role in establishing "ground truth" (beyond analyzing usability findings) is not clarified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Clinical Performance Study: The study design was a "multicenter, prospective, randomized, single-blind, parallel-arm study comparing outcomes of two fitting approaches: self-fitting... or licensed professional fitting." This implies a direct comparison of two defined groups rather than an adjudication process between multiple expert interpretations of a single case. There is no mention of an adjudication method in the traditional sense of resolving discrepancies in expert opinions.
- Usability Testing: A "cross-functional team reviewed outcomes at frequent intervals and addressed changes to be considered to labeling, product packaging, and iterative minor design changes to the user interface." This suggests a collaborative review process rather than a formal adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A traditional MRMC study, as typically applied to image-based diagnostic AI where human readers interpret cases with and without AI assistance, was not explicitly described.
- However, the clinical performance study does compare "Self-fit" (which uses the Sentibo mobile app for self-fitting) to "Pro-fit" (licensed professional fitting). This is a comparative effectiveness study, but it's not in the context of an "AI assistance" model for human readers. It's comparing two different fitting methodologies for a hearing aid device.
- Effect Size: The study demonstrated non-inferiority of the self-fit approach to professional fitting.
  - Satisfaction with Sound Quality: Self-fit mean = 2.84 (SD=0.93), Pro-fit mean = 2.72 (SD=1.14) (on a 5-point scale, where higher is better).
  - Satisfaction with Fitting Process: Self-fit mean = 3.22 (SD=0.95), Pro-fit mean = 3.11 (SD=1.07) (on a 5-point scale, where higher is better).
  - SSQ-12 Benefit Score: Self-fit mean = 6.8 (SD=1.7), Pro-fit mean = 6.5 (SD=1.5) (on a 0-10 scale).
  - APHAB Global Score: Self-fit mean = 10.0 (SD=17.3), Pro-fit mean = 12.8 (SD=19.7).
  - The phrasing "similar levels of satisfaction" and "similar levels of perceived benefit" indicates that the self-fit (AI/app-driven) method performed comparably to professional fitting, demonstrating non-inferiority rather than an "improvement with AI assistance" over a human baseline.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Self-fit" arm of the clinical study, which utilized the "Sentibo OTC mobile app" for fitting, represents a standalone algorithm managing the fitting process, with the user's input as part of the algorithm's execution, rather than an audiologist's direct intervention. The user makes selections based on listening to digitized speech through Apple EarPods. Therefore, the "Self-fit" group in the clinical performance study effectively assessed the standalone performance of the algorithm in guiding the user to fit the device without professional assistance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Performance Study: The ground truth for comparative effectiveness was established by the outcomes of licensed professional fitting (Pro-fit group) using "best practice fitting algorithms" and NAL-NL2 targets, against which the self-fit outcomes were compared for non-inferiority. Subjective outcomes (satisfaction, APHAB, SSQ-12) and objective simulated real-ear measures (matching NAL-NL2 targets) were used.
- Usability Testing: The ground truth was based on the successful completion of tasks by participants and the identification of "critical/essential tasks," reviewed by a cross-functional team.
The sample size for the training set:
- The document does not explicitly state a sample size for a training set for the Sentibo self-fitting algorithm. This type of information (how the algorithm itself was developed or trained on data) is typically for the development stage and not always detailed in an FDA 510(k) summary focused on validation. The Sentibo app offers "24 predefined options" that the user selects from, suggesting a pre-programmed or pre-trained model rather than a user-adaptive learning system that "trains" on user data during the fitting process.
How the ground truth for the training set was established:
- As the training set size is not provided, the method for establishing its ground truth is also not detailed. However, the description of the self-fitting method for the Lumen 155-SF states it "uses digitized human voice" for selection, and that its fitting method is "adequate for fitting mild to moderate hearing loss, the same as prescribed by NAL-NL2." This suggests that the underlying principles and "ground truth" for the algorithm's output (i.e., the 24 predefined options) are based on established audiological standards like NAL-NL2 or similar validated fitting algorithms for different hearing loss profiles. The predicate device uses a validated NAL-NL2 fitting algorithm, and the subject device's method is compared to this standard.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2023

Intricon Corporation David Akbari Senior Medical Science, Clinical and Regulatory Affairs Liaison 1260 Red Fox Road Arden Hills, Minnesota 55112

Re: K223911

Trade/Device Name: Lumen 155-SF Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QUH Dated: August 31, 2023 Received: September 15, 2023

Dear Dr. Akbari:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

Device Name

Lumen 155-SF

Indications for Use (Describe)

The Lumen® 155-SF self-fitting, wireless air conduction hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. The device is intended for over-thecounter sales without the assistance of a hearing health care professional.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of colored dots in shades of blue, green, and gray on the left side. To the right of the dots is the company name, "Intricon," in gray lettering, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.

510K Summary For Device

The 510(k) Summary is provided on the following pages as required by 21 CFR 807.92(c).

1. SUBMITTER INFORMATION

Company Name:	Intricon Inc.
Company Address:	1260 Red Fox RoadArden Hills, MN 55112
Company Contact:	David Akbari,Senior Medical Science, Clinical andRegulatory Affairs Liaison
Email:	dakbari@intricon.com
Phone/Fax:	651-587-8347

2. DEVICE IDENTIFICATION

Trade Name:	Lumen 155-SF Self-Fitting Hearing Aidswith Sentibo Application
Generic Device Name:	Hearing Aid
Classification Name:	Self-Fitting, Air-Conduction Hearing AidOver the Counter
Regulation Class:	Class II
Product Code:	QUH
Assigned K-number:	K223911
Regulation Number:	21 CFR 874.3325
Panel:	Ear, Nose and Throat Devices

3. PREDICATE AND REFERENCE DEVICES

Predicate Device: Nuheara IQbuds™ 2 PRO (K221064) Reference Devices: Bose Sound Control (K211008) Bose De Novo (DEN180026) The predicate and reference device(s) have not been subject to a design-related recall.

4. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray text underneath.

to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are class II medical devices.

Device Characteristics

Materials of Use

The hearing aid makes long term/permanent contact with the skin in and around the ear. The body of the hearing aid rests on the outer shell of the ear (behind the ear) and is coupled to a dome via a slim tube that is worn inside of the ear canal. The materials used in the construction of the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application are biocompatible presenting no biological risk; thus, the requirements of ISO 10993-1 have been met.

Key Performance Specifications

The hearing aids are used with a replaceable, disposable, 1.45V, size 312 zinc air battery. The digital signal processing on the hearing aids allows for the following features to be adjustable: wide dynamic range compression, 16 frequency bands, noise reduction, feedback cancellation, wind noise suppression, low level expansion and microphone arrays (adaptive and fixed microphone directionality).

5. INTENDED USE/INDICATIONS FOR USE

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Image /page/5/Picture/0 description: The image is a logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left, followed by the company name "Intricon" in gray text. Below the company name, the words "MICROMEDICAL TECHNOLOGY" are written in smaller gray text. The logo is simple and modern, and the use of circles suggests innovation and technology.

6. Labeling

Self-Selection Labeling has been included in the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application product label and Instructions for Use (IFU) to mitigate the risk of improper self-selection. Summarized, it addresses the following:

Identifying situations in which the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application may help users hear better;
Identifying situations in which the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application may not be right for users.
Identifying criteria that indicate users should see a hearing professional. -
Informing users that the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with -Sentibo Application will not restore normal hearing.
-Informing users that it is good health practice to have hearing loss evaluated by a licensed healthcare professional.

7. Special Controls

The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application conforms to the special controls stated in 21 CFR 874.3325.

These requirements are satisfied through following:

Clinical Performance Validation -
-Non-clinical Performance Testing
Summative Usability/Human Factors Validation -
-Labeling

8. Comparison of Technological Characteristics with the Predicate

The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application has the same intended use and fundamental technology as the predicate, Nuheara IQbuds 2 PRO (K221064). In the same manner as its predicate, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is a user-fitted wireless air-conduction hearing aid intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment. The same fundamental scientific technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs. The Sentibo application adds a unique element to the assessment by requiring the use of wired Apple EarPods with lightning connector terminus to perform the assessment, after which settings from the simulated model are transmitted to the hearing aid for use. The use of the Apple EarPods to perform the selfassessment and to transfer settings to the hearing aid has been electro-acoustically verified and performs similarly to the predicate device in terms of its measured acoustic output. The subject device is similar to the predicate in product design, dimension, use of Bluetooth technology and utilizing materials of high standard. The principles of operation of the subject device is explained as equivalent to the predicate. The subject device has no known biocompatibility issues, no known effect on the environment, or to other devices. At a high level, the subject and predicate devices are based on the following technological elements:

Self-fitting Air Conduction Hearing Aids -
Wireless Application via Bluetooth -
-On device controls
App (Sentibo Application) -

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Image /page/6/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the spiral is the company name, "Intricon," in a bold, sans-serif font, with the words "MICROMEDICAL TECHNOLOGY" in a smaller font underneath.

Software Platform Compatibility (iOS) -
While both subject and predicate device both have the following elements at a high level, various differences in implementation exist such as the use of rechargeable versus replaceable batteries, and the device embodiment (behind the ear versus in the ear). These differences, where present, do not materially affect the safety or effectiveness of the device.
Batteries (Replaceable, disposable, 1.45 Volt, Size 312, Zinc Air, Batteries) -
Behind-The-Ear (BTE) -
Bi-directional Microphones -
User-Adjustable Tube Length Selection -
-Different size ear tips
Feedback Cancellation -
16 Channel-wide Dynamic Input Compression -
Open Ear Tips in 3 sizes (Small, Medium, Large) -
16 channel Noise Reduction -
-Requires wired Apple EarPods with lightning connector terminus

Any differences between the subject and predicate device have been addressed through testing to a known performance standard. These differences are not significant and do not impact the effectiveness or safety of the subject device.

The intended use and technological characteristics, (e.g., features, parameter settings etc) are similar to the predicate device (Nuheara IQbuds 2 PRO) cited above. The table below summarizes the characteristics of the Lumen 155-SF Hearing Aids in comparison to the predicate and, as applicable, one of the reference devices. The reference device Bose De Novo (DEN180026) serves a reference specific to the self-fitting strategy (i.e., self-administered hearing test and subsequently applied prescription) and clinical trial design, where the Bose Soundcontrol (K211008) is referenced because it uses the same self-fitting strategy as the Bose De Novo and represents a closer physical embodiment match to the subject device in that both are Behind The Ear (BTE) hearing aids. Since the Bose Soundcontrol is a closer physical match to the subject device, this specific reference device is referred to in the following table along with the predicate device as compared to the subject device for the purpose of demonstrating substantial equivalence.

Comparison of Subject and Predicate Devices
	Subject	Predicate	Reference	Discussion ofDifferences
Device TradeName	Lumen 155-SF	NuhearaIQbuds™ 2 PRO	Bose SoundControl
510k Number	K223911	K221064	K211008
Product Code	QUH	QUH	QDD	Same aspredicateThe over-the-counter (OTC)version of the self-fitting hearing aidhas a differentproduct code
Regulation Number	21 CFR 874.3325	21 CFR 874.3325	21 CFR 874.3325	(QUH) todifferentiate it fromthe direct-to-consumer (DTC)version (QDD) asused in the BoseSoundcontrol(K211008)reference device.
Regulation Name	Self-fitting airconduction hearingaid	Self-fitting airconduction hearingaid	Self-fitting airconduction hearingaid, prescription	Same aspredicate
Intended Use	The Lumen 155-SFself-fitting, wirelessair conductionhearing aids withSentibo applicationare intended toamplify sound foradults 18 years ofage or older withperceived mild tomoderate hearingimpairment. They areadjusted by the userto meet the user'shearing needs. Thedevice is intended forover-the-countersales without theassistance of ahearing careprofessional.	The NuhearaIQbuds 2 PROHearing Aids areintended to amplifysound forindividuals withperceived mild tomoderate hearingimpairment. Theyare adjusted by theuser to meet theuser's hearingneeds. No pre-programming orhearing test isnecessary. Thedevice is intendedfor over thecounter sale anduse without theassistance of ahearing care	The Bose HearingAids are intendedto amplify soundfor individuals 18years of age orolder withperceived mild tomoderate hearingimpairment. Theyare adjusted by theuser to meet theuser's hearingneeds. No pre-programming orhearing test isnecessary. Thedevice is intendedfor direct-to-consumer sale anduse without theassistance of ahearing care	Similar topredicate andreference BoseSoundcontrol(K211008)The clause "nopre-programmingor hearing test isnecessary" wasomitted in thesubject device asredundant in thecontext of a self-fitting hearing aid.
Indications forUse	The Lumen 155-SFHearing Aids areintended to amplifysound for adults 18years of age or olderwith perceived mild tomoderate hearingimpairment. It isadjusted by the userto meet the user'shearing needs. Nopre-programming orhearing test isnecessary. Thedevice is intended forover-the-countersales without theassistance of a	professional.The NuhearaIQbuds 2 PROself-fitting hearingaids are intendedto amplify soundfor individuals 18years and olderwith perceived mildto moderatehearingimpairment. Theyare adjusted by theuser to meet theuser's hearingneeds. No pre-programming orhearing test isnecessary. The	professional.The BoseSoundControlHearing Aids areintended to amplifysound for adults 18years of age orolder withperceived mild tomoderate hearingimpairment. It isadjusted by theuser to meet theuser's hearingneeds. No pre-programming orhearing test isnecessary. Thedevice is intendedfor direct-to-	Same aspredicate andreference BoseSoundcontrol(K211008)
	hearing careprofessional.	device is intendedfor over-the-counter sale anduse without theassistance of ahearing careprofessional	for over-the-counter saleswithout theassistance of ahearing careprofessional.
Technology(batteries)	312 zinc-air [non-rechargeable]hearing aid batteries	RechargeableLithium- ionpolymer batteries	312 zinc-air [non-rechargeable]hearing aidbatteries	Same asreference BoseSoundcontrol(K211008)Subject devicebattery is non-rechargeable whilethe predicate is arechargeable. Thepredicate NuhearaIQbuds 2 PRO(K211064)recharges by useof an AC plugadapter andconnector torecharge, andcannot be usedwhile charging.The subject deviceuses disposablezinc-air 312batteries with drainnoted in the ANSIS3.22 standard.The difference inbatteries does notintroduce newquestions of safetyas both devicesmeet therespectiveperformancerequirements forbattery drain basedon the technologyused.
Housing	Image: Behind-the-ear (BTE)	Image: In-the-ear (ITE) hearing aid	Image: Behind-the-ear (BTE)	Same asreference BoseSoundcontrol(K211008)Although thesubject devicehearing aid

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	hearing aid housing.Separate left andright ear units(earbuds) with usercontrol push buttonson each unit.Sold in pairs	housing. Separateleft and right earunits (earbuds)with a separate EarTip for each unit.On device, 'TapTouch' control tostreaming audioand use withphone (viaBluetooth)Sold in pairs	hearing aidhousing. Separateleft and right earunits (earbuds)with user controlpush buttons oneach unit.Sold in pairs	behind-the-earstyle instead of anin-the-ear style, thedifference inhousing does notraise differentquestions of safetyor effectivenesssince both aretested to the sameelectroacousticstandards(ANSI/ASA S3.22via reference inANSI/CTA 2051).
Input signalcompression	Multichannel, widedynamic rangecompression	Wide dynamicrange compression	Multichannel, widedynamic rangecompression	Same asreference BoseSoundcontrol(K211008)The subject,predicate, andreference devicesall feature a form ofwide dynamicrangecompression. Theway in whichfrequency sub-divisions are usedby the processingalgorithm do notraise differentquestions of safetyor effectivenesssince both subjectand predicateNuheara IQbuds 2PRO (K221064)devices are testedto the sameelectroacousticstandards.
Microphones	Omnidirectional orDirection modes	Omnidirectional orDirection modes	Omnidirectional orDirection modes	Same aspredicate andreference BoseSoundcontrol(K211008)
Battery Life	100 hours(312 zinc-air [non-rechargeable] hearingaid batteries)	Per CTA 2051(4.1-4.17) Batterylife of up to 8 hrs	56 hoursUp to 4 days,assuming 14hr dayusage.(312 zinc-air [non-rechargeable]	Same asreference BoseSoundcontrol(K211008)
			hearing aidbatteries)	Battery draindiffers betweenrechargeable anddisposablebatteries and doesnot raise anydifferent issues ofsafety andeffectiveness.
Noise Reduction	The Lumen 155-SFfeatures multi-layeredadaptive noisereduction withselectable intensity(Low 7 dB, Medium10 dB, High 13 dB,Max 17 dB)	Hybrid ActiveNoise Cancellation	Steady state noisereduction	The subject deviceperforms in asimilar manner tothe predicateNuheara IQbuds 2PRO (K221064)and referencedevice BoseSoundcontrol(K211008) byreducing hearingaid output inresponse todetected noisesignals. Themethod ofdetection andamount of gainreduction inresponse toenvironmentalnoise utilizedifferentproprietarymethodologies andwere considered incontext in theclinical data for thesubject, predicate,and referencedevices. Thespecific algorithmdifferences do notraise differentissues of safetyand effectiveness.
Self-fittingmethod	User selects theirpreferred audiosettings by listeningto a smartphoneusing Apple lightningconnector wiredEarPods. Usersaudition theirpreferred settingsbased on predefinedset of 24 options	Device uses aproprietary Ear ID,a validated NAL-NL2 fittingalgorithm	Adequate for fittingmoderate hearingloss (55 dB HL) asprescribed by NAL-NL2	The predicateNuheara IQbuds 2PRO (K221064)device uses theNAL/NL2 self-fittingmethod whichdepends on theacquisition of puretone audiometricthresholds,whereas the

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		subject device'sfunctionally similarself-fitting methoduses digitizedhuman voice. Thesubject device'sfitting method isadequate for fittingmild to moderatehearing loss, thesame asprescribed by NAL-NL2. Sentibo OTCprovides 24predefined options.In the subjectdevice, AppleEarPods arerequired while theyare not required foreither predicateNuheara IQbuds 2PRO (K221064) orreference devices.The subject devicehas beenmeasured andvalidated in-situ todemonstrate thatthe EarPodpresented runningspeech range isthe basis by whichthe hearing aidalso performswhen used with itsvolume control andinput-controlledcompression.Because thesubject devicemeets the sameelectroacoustic teststandards as thepredicate andreference devices,no differentquestions of safetyor effectivenessare introduceddespite thetechnologicaldifferences in fitting

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Mobile App	Mobile application ona smart device(phone or tablet) withiOS platform	Mobile applicationon a smart device(phone or tablet)with either iOS orAndroid platforms	Mobile applicationon a smart device(phone or tablet)with either iOS orAndroid platforms	Similar toPredicate andReference DeviceBoseSoundcontrol(K211008), exceptsubject device isnot compatible withAndroid platform
Remotefirmwareupdates	Not supported	The subject devicevia the Nuhearaapp allows forremote firmwareupdates to thehearing aids.	The hearing aidsupdateautomatically whenconnected to theBose Hear app.Follow the appinstructions.	Subject devicedoes not allow forremote firmwareupdatesWhile the subjectdevice does notsupport remotefirmware updatesand both thepredicate NuhearaIQbuds 2 PRO(K221064) andreference deviceBose Soundcontrol(K211008) do, thesubject, predicate,and referencedevice all conformto similar wirelessrecognizedconsensusstandards. Sincethe subject devicedoes not allow thepotential forfirmwaremodificationwirelessly, no newquestions of safetyor effectivenessare introduced.

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Electro-Acoustic Characteristics per ANSI/ASA S3.22 and ANSI/CTA 2051:2017 (and ANSI/ASA S3.22 by reference)

	Subject	Predicate	Reference	Discussion ofDifferences
Device TradeName	Lumen 155-SF	NuhearaIQbuds™ 2 PRO	Bose SoundControl	Same as predicateNuheara IQbuds 2PRO (K221064)within measurementuncertaintytolerance. Thesubject, predicate,and reference BoseSoundcontrol(K211008) devicesall haveprogrammablelatency, and all areless than or equal to15 ms as specifiedin ANSI/CTA 2051.
510k Number	K223911	K221064	K211008
Latency clause4.8	5.8 ms	5 ms	5.5 ms
Frequencyresponse	< 200 Hz - 8000 Hz	200 Hz - 8000 Hz	< 200 — 8000 Hz	The subject devicemeets therequirements, sameas the predicate.
Input distortionclause 4.4.2	Less than or equalto 5% (measure is1.2%)	Less than or equalto 5% (measure is0.7%)	Less than or equalto 5%	The subject devicemeets therequirements, sameas the predicate.
Equivalent InputNoise (EIN)(Self-generatedNoise Levels)Clause 6.12	26.4 dB SPL	28.5 dB SPL	< 23 dB SPLtypical,< 27 dB SPL max	The subject devicemeets therequirements, sameas the predicate.
HarmonicDistortionClause 6.11	<0.5% typical, <1%max	0.2%	< 0.5% typical, <1% max	The subject devicemeets therequirements, sameas the predicate.The resultsdescribing "typical"and "max" are fromrepeated measureson multiple units inorder to confirm thevalues as it relates

				to the ANSI/ASAS3.22 test forharmonic distortion.The differencebetween the slimtube embodiment ofthe subject deviceand the ITEembodiment of thereference device willresult in slightlydifferent valuesbetween the units,but both devicesmeet the sameelectroacousticrequirements.
Max OSPL90Clause 6.2	114.4 dB SPL	109.6 dB SPL	113 dB SPL	The subject devicemeets therequirements, sameas the predicate.The subject,predicate NuhearaIQbuds 2 PRO(K221064), andreference deviceBose Soundcontrol(K211008) featureoutput limiting andinput-controlledcompression andshow OSPL90values that are lessthan the maximumallowable 117 dBSPL limit.
HFA OSPL90Clause 6.3	109.6 dB SPL	100.9 dB SPL	106 dB SPL	The subject devicemeets therequirements, sameas the predicate.
HFA FOGClause 6.5	51 dB	29.4 dB SPL	30 dB	The subject devicewill provide moreamplification for softsound inputs. Nospecific gain limitwas identified orrequired in the finalOTC rule. Whilehigher than thepredicate NuhearaIQbuds 2 PRO(K221064) andreference BoseSoundcontrol

			(K211008) devices,device gain isdependent on theinput. Since thesubject devicefeatures outputlimiting which isalways enabled, nodifferent questionsof safety or efficacyare introduced as aresult of thisdifference.
Reference TestGain (RTG)Clause 6.7	45 dB	24.4 dB SPL	29 dB	The subject devicemeets therequirements, sameas the predicateNuheara IQbuds 2PRO (K221064).Reference TestGain is descriptiveonly according toANSI/ASA S3.22.Where differencesbetween the subjectdevice andpredicate deviceexist, no differentquestions of safetyor efficacy areintroduced.

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Image /page/15/Picture/0 description: The image shows the logo for Intricon, a micro medical technology company. The logo consists of a circular pattern of blue, green, and gray dots on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font. The logo is clean and modern, and the use of color suggests innovation and technology.

9. NON-CLINICAL PERFORMANCE DATA

The subject device was tested for conformity to the following FDA recognized consensus standards applicable to the self-fitting hearing aid for its intended use.

Biocompatibility

ISO 10993-1 Biological evaluation of medical devices ●
ISO 10993-12 Biological evaluation of medical devices
ISO 10993-5 Biological evaluation of medical devices ●
ISO 10993-10 Biological evaluation of medical devices ●

Electro-Acoustics

ANSI/ASA S3.22 2014 (R2020) Measurements ●
. ANSI/CTA 2051 2017

In order to establish substantial equivalence to the predicate device. Intricon evaluated the electroacoustic data as found in the predicate and required under Special Controls for 21 CFR §874.3325. As seen in the Electroacoustic Characteristics per ANSI S3.22 and CTA 2051:2017 table above, the measurement for the specific cited clauses indicates that the Lumen 155-SF hearing aid(s) with Sentibo application are

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substantially equivalent in acoustic performance to the predicate device, Nuheara IQbuds 2 PRO (K221064).

10. Electrical Safety, EMC, Battery Safety, Software, and Labeling

Consistent with the predicate device, the Lumen 155-SF Hearing Aid(s) with Sentibo application passed all relevant non-clinical performance testing and biological endpoints, namely cytotoxicity (ISO 10993-05:2009) sensitization, and intracutaneous reactivity (ISO 10993-10:2010). Similarly, software verification and validation, testing to established consensus standards for electrical safety, EMC and battery safety demonstrated mitigation of risks to an acceptable level as well as reasonable assurance of safe and effective device non-clinical performance, consistent with the predicate and reference devices, the Nuheara IQbuds 2 PRO, and the Bose Soundcontrol Hearing Aid, respectively.

Standard	Test Purpose	Result
IEC 60118-13:2016EMCElectroacoustics -Hearing aids - Part13: Electromagneticcompatibility	To demonstrate hearing aid compliance to theIEC 60118-13 EMC requirements	Pass
BS EN 60601-2-66:2015Basic Safety andEssentialPerformance of Air-Conduction HearingAids	To verify that the hearing aid complies with thebasic safety and essential performancerequirements of the particular standard BS EN60601-2-66:2015, Medical Electrical Equipment –Part 2-66: Particular Requirements for the BasicSafety and Essential Performance of HearingInstruments and Hearing Instrument Systems andthe general standard, BS EN 60601-1:2006+A1:2013, Medical Electrical Equipment –Part 1: General requirements for Basic Safetyand Essential Performance	Pass
BS EN 60601-2-66:2015Patient LeakageCurrent Results forHearing Aids	To demonstrate conformity with clause 201.8.7 ofBS EN 60601-2-66 to assure basic safety andessential performance of the hearing aids.	Pass
IEC 60601-1-2:2015Medical electricalequipment - Part 1-2: Generalrequirements forbasic safety andessentialperformance -	Electromagnetic Compatibility	Pass

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Collateral Standard:Electromagneticdisturbances –Requirements andtests
IEC 60601-1-11Vibration and ShockEnvironmentalTesting Results forthe Lumen 155	To demonstrate the conformity of shock andvibration characteristics of the Lumen 155 airconduction hearing devices as per IEC 60601-1-11.	Pass
FCC & RED Tests -Lumen 155 (L 155)Wireless	To provide evidence that the Lumen 155 wirelesshearing instrument platform meets theelectromagnetic requirements of the FederalCommunications Commission	Pass
AAMI TIR69WirelessCoexistence RiskAnalysis for AirConduction HearingAids	To review the risks associated with WirelessCoexistence for Air Conduction Hearing Aids	Pass
IEEE / ANSIC63.27:2017 –Evaluation ofWirelessCoexistence	Bluetooth SIG Compliance	Pass
ANSI C63.19: 2019– Methods ofMeasurement ofCompatibilityBetween WirelessCommunicationsDevices andHearing Aids	Radio Frequency Immunity	Pass

Note: Full Non-clinical Performance Testing results, including acceptance criteria and testing performance are reported in the 510(k) submission.

11. USABILITY TESTING AND CLINICAL PERFORMANCE DATA

Usability Testing

In the usability analyses, preliminary analysis along with design changes intended to reduce the identified use-related risks were implemented iteratively throughout the product development process. Analytical methods were used to identify 'critical/essential' tasks.

Fifteen adults (18 yrs. and older) with a perceived mild to moderate hearing loss

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were enrolled after passing screening of inclusion/exclusion criteria. Task driven Formative Evaluations followed by an inclusive Summative Evaluation were conducted in a one-on-one quiet, comfortable room fit with two chairs and a table on which the participants could handle the device and a smartphone. Informed Consent was obtained for each participant before enrollment and all sessions were video-taped.

While no tasks were identified that met the criteria for 'critical' there were 3 deemed 'essential' (device is not hearing protection and other warnings/cautions from the User Guide). An independent, trained moderator conducted each session which involved a series of steps for accessing, fitting and then using the hearing aid in simulated use conditions. All participants were scored on status of completion of all steps in each of the tasks. A cross-functional team reviewed outcomes at frequent intervals and addressed changes to be considered to labeling, product packaging, and iterative minor design changes to the user interface to accommodate the user needs. The same crossfunctional team reviewed and approved the Summative Evaluation Report. The evaluation provided evidence that the device was safe and effective to operate by the intended user when used in accordance with its intended use.

Overall, the human factors study demonstrated that the usability of the Lumen 155-SF hearing aid(s) with Sentibo application were analyzed, verified, and validated for its intended use and the implemented mitigations for user training and device labeling are adequate.

Clinical Performance

Clinical Performance with the Lumen 155-SF Hearing Aid(s) with Sentibo application were assessed with a multicenter, prospective, randomized, single-blind, parallel-arm study comparing outcomes of two fitting approaches: self-fitting with Sentibo OTC mobile app (Self-fit) or licensed professional fitting (Pro-fit) with the same hearing aid device.

The primary objective of this study was to demonstrate non-inferiority of satisfaction outcomes of participants using the self-fit Sentibo OTC mobile app (Self-fit) when compared to licensed professional-fit (Pro-fit) hearing aids.

The secondary objectives were:

To evaluate the quality of hearing in typical consumer use. -
To evaluate the participants' perceptions of benefit. -
-To assess satisfaction among naïve and experienced users.
To estimate the rate of device-related adverse events. -

The exploratory objectives were:

To verify the acoustic conditions likely to be present at the eardrum by the hearing aid.
To validate the acoustic conditions provided by the self-fit app. -

Participants included 93 adults self-identified with perceived mild-to-moderate hearing loss. This validation of the Lumen 155-SF with Sentibo self-fitting methodology for the target population (adults with perceived mild to moderate hearing loss) used an assessment approach similar to that of the reference device Bose Soundcontrol Hearing

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Aid (K211008) by assessing clinical effectiveness quantitatively and qualitatively. Those measures involved the following described by endpoint objective:

Primary objective assessment. To meet the primary objective of demonstrating noninferiority of satisfaction outcomes of participants using the self-fit Sentibo OTC mobile app (Self-fit) when compared to licensed professional-fit (Pro-fit) hearing aids, participants completed two 5-point satisfaction scales, one which assessed their satisfaction with their hearing aids' sound quality and one which assessed their satisfaction with the fitting process.

Secondary objective assessment. In addition to rating scales modeled after the reference device, to meet secondary objectives about perceived benefit and quality of hearing, participants completed the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Speech, Spatial and Qualities Hearing Scale (SSQ-12). The APHAB assesses a participant's perceived benefit of wearing hearing aids on the ease of communication in a variety of contexts (e.g., background noise, reverberation) and aversiveness to sound. The SSQ-12 asks respondents to consider listening to speech in a variety of contexts that vary in distance, movement, and direction.

Exploratory objective assessment. To meet the exploratory objectives of verifying the acoustic conditions likely to be present at the eardrum by the hearing aid and validating the acoustic conditions provided by the self-fit app, simulated real-ear measures were obtained using a KEMAR manikin to represent the characteristics of the average acoustic response of the head, neck, torso, pinna, and ear canal. A VeriFit 2 real-ear analyzer was used to present acoustic stimuli to the manikin in the free-field condition. Individual participant thresholds were entered in order to generate NAL-NL2 targets, and both pro- and self-fit settings were measured, regardless of group assignment. Hearing aid output was documented for the International Speech Test Stimulus (ISTS) presented at 50 (soft), 65 (mid), and 80 (loud) dB SPL with a Maximum Power Output (MPO) tone sweep at 85 dB SPL. All measurements were obtained at the default volume control level (a level of 0 between +10 and -10 dB from the programmed level). All measures were obtained with input-controlled compression and volume control active and in place.

Image /page/19/Figure/7 description: The image is a flowchart titled "Figure 1. Participant timeline." The flowchart shows the steps in a research study, starting with "Audiometry Review & Screening" and ending with "Video Session 4 Complete Questionnaires." There are two groups in the study, a PF Group and a SF Group. The study involves 5 days of field use and 30 days of field use.

The study was designed to adhere to COVID-19 social distancing needs. The COVID-19 pandemic offered a unique opportunity to study Sentibo under the contact-free conditions for which it is intended. All questionnaires, wellness checks, and communication between the study's audiologists and the participants were administered through appropriate remote means (e.g., video conference calls and email).

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						Table 1. Study Events and Assessments
--	--	--	--	--	--	---------------------------------------

	Screening &Baseline	VideoSession 1SentiboSelection	VideoSession 2First fit	Field Use~ 5 days	VideoSession 3Fine tuning	Field Use~ 30 days	VideoSession 4 Final	PostParticipantStudy Exit
Eligibility Assessment	×
Informed Consent		×
Point of Enrollment		×
Randomization		×
Demographics & Medical HearingHistory		×
Otoscopy Exam Provided	×
Audiogram Provided	×
Sentibo Listening & SelectionProcess Prior to Hearing Aids		×
Initial Fitting (PF or SF)			×
Fine Tuning (PF or SF)					×
Participant Questionnaires(Satisfaction, SSQ-12 and APHAB)							×
Adverse Event Evaluation			×	×	×	×	×
Simulated Real-Ear Measures								×
Optional Ongoing Support fromHearing Help Express								×

Ninety-five English speaking adults (one had English as a second language) with selfperceived mild-to-moderate hearing loss were consented and enrolled in the Satisfaction with Self-Fitting Hearing Aid Software Compared to Licensed Professional-Fitting of the Same Hearing Aid Device clinical trial. Three participants departed the study after consenting for reasons not related to the hearing aid or Sentibo fitting strategy. One participant decided not to participate after consenting but did not start the protocol, a second participant was lost to follow-up after the initial hearing aid fitting, and a third participant had an unforeseen death in the family and was not available during their appointments. Therefore, 92 participants provided data for analyses.

All participants were required to provide an audiogram and otoscopic clearance obtained by a licensed professional within 6 months of their consent date. Exclusion criteria included a history of significant middle ear disease, surgical remediation of the ear, and congenital anomaly. The potential participant was excluded if the audiogram indicated a significant discrepancy between self-reported mild-to-moderate hearing loss and the audiological report (e.g., profound hearing loss). The participants were randomly assigned to either the self-fit (Self-fit) or the pro-fit (Pro-fit) group. Tables 2 and 3 present detailed demographic and audiological information for both groups.

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Table 2. Demographic data

	Self-Fit	Pro-Fit
Sample Size	45	47
Age (years) mean, s.d.	66.1; 10.1	63.8; 14.4
Female / Male (# participants)	26 / 19	30 / 17
Married / Divorced / Single / Widowed	33 / 7 / 2 / 3	36 / 3 / 5 / 3
Number of people in home (sd)	2.2 (0.8)	2.6 (1.2)
Full Time / Part Time / Retired / NotEmployed	15 / 5 / 23 / 2	16 / 7 / 21 / 3
Years of education (sd)	15.4 (2.1)	15.7 (2.1)
# With previous HA experience / #without HA experience	12 / 33	17 / 30
# With > 5 years smartphoneexperience / # with < 5 yearsexperience	39 / 6	42 / 5
Primary Smartphone OS experienceApple / Android / Both	36 / 5 / 4	35 / 6 / 6

Table 3. Audiological data

	Self-Fit	Pro-Fit
Sample Size	45	47
4F PTA (dBHL; s.d.)	Right Ear=36.0; 14.1Left Ear=35.7; 13.9	Right Ear=33.5; 13.6Left Ear=34.0; 14.7
Sensorineural (# participants)	44	42
Mixed* (# participants)	1	5
Asymmetrical** (# participants)	2	6

*Air Bone Gap is >15db at 500Hz, 1000Hz and 2000Hz,

** Average PTA at 500Hz, 1000Hz, 2000Hz and 4000Hz is >15dB between ears

Figure 2 shows the means and standard deviations at each audiometric test frequency for each group. No significant differences were found between groups at any test frequency.

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Figure 2. Audiometric Thresholds

Image /page/22/Figure/4 description: The image shows a graph of average air conduction audiograms versus frequency. The x-axis represents frequency in Hertz (Hz), with values ranging from 250 to 8000. The y-axis represents air conduction threshold in decibels Hearing Level (dB HL), ranging from -90 to 0. Two groups are compared: Pro-Fit and Self-Fit, with error bars indicating one standard deviation from the mean.

Average Air Conduction Audiograms versus Frequency (Hz)

Study Results

The primary objective of this study was to demonstrate the noninferiority of outcomes for participants who use new hearing aids that have been programmed with the self-fit Sentibo OTC mobile app (Self-fit) versus hearing aids that have been programmed by an audiologist using commercially available fitting software (Pro-fit). Both Self-fit and Pro-fit groups yielded similar levels of satisfaction for the sound quality of their hearing aids (Figure 3) and with the fitting process (Figure 4).

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Image /page/23/Figure/3 description: The image shows the title of a figure. The title is "Figure 3. Responses to the sound quality question."

Image /page/23/Figure/4 description: The image is a bar chart titled "Satisfaction with Sound Quality". The x-axis shows the satisfaction levels: Very Dissatisfied, Dissatisfied, Neither, Satisfied, and Very Satisfied. The y-axis shows the count, ranging from 0 to 25. The chart compares the satisfaction levels between the Pro-Fit Group and the Self-Fit Group.

Figure 4. Responses to the fitting process question.

Image /page/23/Figure/6 description: This bar graph shows the satisfaction with the fitting process. The x-axis shows the satisfaction levels: Very Dissatisfied, Dissatisfied, Neither, Satisfied, and Very Satisfied. The y-axis shows the count from 0 to 25. The Pro-Fit group and Self-Fit group are compared at each satisfaction level.

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Question 1

Pro-fit mean of 2.72 (SD=1.14) -
Self-fit mean of 2.84 (SD=0.93) -

Question 2

Pro-fit mean of 3.11 (SD=1.07) -
Self-fit mean of 3.22 (SD=0.95) -

Figures 5 and 6. Comparison of the overall scores for the two questions.

Image /page/24/Figure/10 description: The image contains two boxplots comparing satisfaction scores between Pro-Fit and Self-Fit groups. The left boxplot shows satisfaction with sound quality, while the right boxplot shows satisfaction with the fitting process. Both boxplots display satisfaction scores on the y-axis, ranging from 0 to 4.5, and the Pro-Fit and Self-Fit groups are represented on the x-axis, with blue and red boxes, respectively.

The secondary objectives were to evaluate the quality of hearing in typical consumer use, to evaluate the participants' perceptions of benefit, to assess satisfaction among naïve and experienced users, and to estimate the rate of device-adverse events. Results from the SSQ-12 and APHAB appear in Table 4.

	Self-fitMean (SD, Range)	Pro-fitMean (SD, Range)
SS Questionnaire #1	2.8 (0.9, 0 - 4)	2.7 (1.1, 0 - 4)
SS Questionnaire #2	3.2 (1.0, 0 - 4)	3.1 (1.1, 0 - 4)
SSQ-12 Benefit Score	6.8 (1.7, 1 - 10)	6.5 (1.5, 3 - 10)
APHAB Global Score	10.0 (17.3, -25 - 50)	12.8 (19.7, -25 - 55)

Table 4. Test results

The SSQ-12 focuses on the listener's perceived ability to perform across twelve different listening environments. The output is an average of all scores that ranged from Not at all (0) to Perfectly (10). The overall mean score for the Self-fit group output scores on the

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Image /page/25/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text. Below the company name is the phrase "MICROMEDICAL TECHNOLOGY" in smaller, gray text.

SSQ-12 were 6.8 (SD=1.7) and for the Pro-fit group, 6.5 (SD=1.5), indicating that the two groups had similar levels of perceived benefit.

The scores on the APHAB are determined by calculating the benefit associated with wearing a hearing aid. Participants evaluate their ability in everyday situations both with and without a hearing aid on a seven-point scale. Benefit scores are calculated as a difference between performance with a hearing aid and performance without an aid. The standard outcome for the APHAB is a global benefit score which provides an index of the benefit a person receives from their hearing aid. The overall mean score for the Selffit group was 10.0 (SD=17.3) and for the Pro-fit group, 12.8 (SD=19.7), indicating that the two groups had similar levels of perceived benefit.

The exploratory objective of this study was to quantitatively confirm measured sound pressure levels at the ear canal in order to document safety and examine efficacy. As shown in Figure 7 the actual maximum output SPL for the MPO test among all participants in all conditions was 101.3 dB SPL (n=184 ears). Figures 8, 9, and 10 show measured results from the hearing aid in-situ minus the NAL-NL2 targets for both the Pro-fit and Self-fit groups which resulted in similar matches to NAL-NL2 targets by frequency.

Figure 7. Overall Maximum Sound Pressure, Pro-fit and Self-fit groups combined

Image /page/25/Figure/7 description: The image shows a graph titled "Maximum Power Output, Pro-fit and Self-fit Groups Combined, 85 dB SPL Swept Tone Input". The graph plots frequency in Hz on the x-axis, ranging from 250 to 16000, and dB SPL in KEMAR (IEC 60318-4 Coupler) on the y-axis, ranging from -10 to 140. There are multiple orange lines clustered together, showing a general trend of increasing dB SPL as frequency increases from 250 Hz to around 2000 Hz, then fluctuating between 80 and 100 dB SPL. A dashed black line is also plotted, showing a lower dB SPL value that increases with frequency.

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Image /page/26/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray letters underneath.

Figure 8. Measured results from the hearing aid minus NAL-NL2 targets for soft level inputs.

Image /page/26/Figure/4 description: The image is a boxplot comparing 'Pro-fit' and 'Self-fit' hearing aid settings, showing the difference between measured and target values in decibels (dB) across various frequencies in Hertz (Hz). The data represents soft inputs at 50 dB SPL. The x-axis displays frequencies ranging from 250 Hz to 8000 Hz, while the y-axis shows the 'Measured - Target' difference in dB, ranging from -40 to 20. The boxplots indicate the distribution of differences at each frequency for both 'Pro-fit' and 'Self-fit' settings.

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Image /page/27/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo features a spiral of blue, green, and gray circles on the left. To the right of the spiral is the word "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.

Figure 9. Measured results from the hearing aid minus NAL-NL2 targets for medium level inputs.

Image /page/27/Figure/4 description: The image is a boxplot comparing "Pro-fit" and "Self-fit" measurements relative to a target, with "Measured - Target (dB)" on the y-axis and "Frequency (Hz)" on the x-axis. The title indicates "Measured minus Target" for "Mid Inputs (65 dB SPL)". The y-axis ranges from -40 to 20 dB, while the x-axis spans frequencies from 250 to 8000 Hz. The plot shows the distribution of differences between measured and target values for both "Pro-fit" and "Self-fit" at various frequencies.

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Image /page/28/Picture/0 description: The image contains the logo for Intricon, a micro medical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.

Figure 10. Measured results from the hearing aid minus NAL-NL2 targets for high level inputs.

Image /page/28/Figure/4 description: The image is a boxplot comparing the measured minus target values in decibels (dB) for loud inputs at 80 dB SPL across different frequencies in Hertz (Hz). The x-axis represents frequency, ranging from 250 Hz to 8000 Hz, while the y-axis represents the difference between the measured and target values in dB, ranging from -40 dB to 20 dB. The plot compares two conditions, 'Pro-fit' and 'Self-fit', with each frequency having two boxplots showing the distribution of the measured minus target values for each condition.

Figure 11 presents the Bland-Altman analysis for all ears. All participants, regardless of group assignment, provided setting data from both the Self-fit procedure and the Pro-fit procedure. The vertical axis of the graph shows differences within participants between their pro-fit and self-fit settings. The horizontal axis is the average dB SPL of the same person's pro-fit and self-fit settings. The vertical lines between one and two standard deviations are the group mean values for soft, medium, and loud inputs, respectively. Values that fall outside the two standard deviation range towards the top of the graph (pro-fit louder than self-fit) mean that the participant was over-fit relative to their NAL-NL2 generated targets, or simply self-selected softer settings than what would have been prescribed by NAL-NL2. Values that fall outside the two standard deviation range towards the bottom of the graph (Self-fit louder than Pro-fit) mean that some participants at some frequencies had a propensity to select louder than what was prescribed to them via NAL-NL2. Both Pro-fit and Self-fit settings were similar in their resulting SPL at the ear canal, documenting similar efficacy of the fitting techniques despite there being minor differences in the technological characteristics.

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Image /page/29/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray dots on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller font.

Image /page/29/Figure/3 description: The image is titled "Figure 11. Bland-Altman analysis of all ears in both Pro-fit and Self-fit groups". The image is a title for a figure. The title describes that the figure is a Bland-Altman analysis.

Image /page/29/Figure/4 description: This figure is a Bland-Altman plot with data from 184 ears. There are 1,880 points per input level, for a total of 5,640 points. The plot shows the difference between Pro-fit and Self-fit (in dB) on the y-axis, and the average of Pro-fit and Self-fit (in dB SPL) on the x-axis. The data is separated into three categories: Soft Input (50 dB SPL), Medium Input (65 dB SPL), and Loud Input (80 dB SPL).

The methodology and design of this study was in line with the clinical evaluation of the reference device Bose De Novo (DEN180026) (subjective and objective performance outcomes). These results were also referenced in the 510(k) Summary for the Bose SoundControl BTE hearing aid (K211008) which is a closer physical embodiment to the subject device in that they are both BTE style hearing aids. The results demonstrate that the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application were noninferior to fitting by an audiologist using best practice fitting algorithms. Effectiveness is also substantially equivalent to the predicate device (Nuheara IQbuds 2 PRO), which was similarly demonstrated to be substantially equivalent to subjective and objective performance outcomes demonstrated in the Bose De Novo (DEN180026) clinical study design referenced by the Bose Soundcontrol (K211008).

This validation of the Sentibo OTC self-fitting methodology for the target population (adults with perceived mild to moderate hearing loss) used an assessment approach similar to that of the reference and predicate devices (Bose Soundcontrol K211008 and Nuheara IQbuds™ 2 PRO K221064 respectively).

12. SUBSTANTIAL EQUIVALENCE

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Image /page/30/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.

The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application has the same intended use as the predicate device, the Nuheara IQbuds 2 PRO (K221064). Like the predicate device, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is a user-fitted, wireless, air-conduction hearing aid, intended for over-thecounter use by individuals 18 years or older with perceived mild to moderate hearing impairment. Clinical data shows that the effectiveness of the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is non inferior to fitting by a licensed audiologist with a calibrated clinical audiometer for both self-fitting hearing assessment. Furthermore, human factor testing displayed a high level of user satisfaction and is therefore substantially equivalent to the predicate device in acoustic performance, usability, and safety. Non-clinical performance testing has been conducted to ensure that the device does not raise any questions of safety and effectiveness as established by the predicate device. Device and application firmware and software have been validated per the same standards as used to validate the device and application firmware and software of the predicate device. Lastly, design verification results demonstrate that the subject device has substantially equivalent performance to the predicate device. Lumen 155-SF Hearing Aids are substantially equivalent in intended use and fundamental scientific technology to the Nuheara IQbuds™ 2 PRO Hearing Aids (K221064) and reference devices Bose SoundControl Hearing Aids (K211008) and Bose De Novo (DEN180026). The Bose De Novo (DEN180026) reference device is leveraged for its clinical study design as it demonstrates the safety and efficacy of the self-fitting strategy, while the Bose Soundcontrol (K211008) is leveraged for its use of the same fitting strategy used in the Bose De Novo while being a closer match to the physical embodiment of the subject device in that they are both BTE hearing aids. The Lumen 155-SF Hearing Aids are considered as safe and effective as the predicate device for its intended use when used in accordance with its Instructions for Use.

13. Conclusion

The special controls for self-fitting hearing aids as per 21 CFR 874.3325, are met in the following aspects; the clinical data has evaluated the effectiveness of the self-fitting strategy, the electroacoustic parameters (including max output limits, distortion levels, self-generated noise levels, latency, and frequency response) were specified and tested, performance data demonstrates the EMC, electrical and thermal safety of the device. The software verification, validation, and hazard analysis has been performed. The wireless technology performance testing has validated safety of exposure to non-ionizing radiation and validation of wireless technology functions. The usability testing has demonstrated that users can correctly use the device as intended under anticipated conditions of use. In conclusion, the evidence provided demonstrates that the outcomes of the Sentibo self-fit model (with Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application) are comparable to an audiologist's best-practice model. Based on the comparison and analysis above, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is determined to be substantially equivalent to the predicate device (Nuheara IQbuds 2 PRO K221064).

Regulation Number and Section

§ 874.3325 Self-fitting air-conduction hearing aid.

(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.