The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional.

Device Description

The Soundwave Hearing, Sontro® OTC (over-the-counter) Hearing Aids are self-fitting wireless air conduction hearing aids consisting of the hardware and software: the device uses the otoTune® app and accessories supplied in the carton. Each hearing aid in the pair functions and interacts with the otoTune® app independently and as a system.

A disposable size 312 zinc-air battery powers the hearing aids. The hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver in the canal that can be coupled with ear domes. The hearing aids are controlled via onboard button controls and wirelessly via the otoTune® app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Sontro® OTC Hearing Aids (AI), based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria (Endpoint)	Reported Device Performance	Non-inferiority Criterion Met?
Primary Effectiveness:
SELF-FIT REAR equivalent to CLINIC-FIT NAL/NL2 prescription REAR targets (in-lab)	Average REAR differences (CLINIC-FIT - SELF-FIT) for both ears: 0.17 dB. 95% CI: (-0.44, 0.78).	Yes (CI within +/- 5 dB)
SELF-FIT APHAB global score non-inferior to CLINIC-FIT APHAB global scores (wear-time field trial)	Average APHABglobal differences (CLINIC-FIT - SELF-FIT): 1.93. 95% CI: (-4.35, 8.21).	Yes (CI upper bound < 8.4)
Primary Reliability:
SELF-FIT REAR (A) equivalent to SELF-FIT REAR (B) (in-lab)	Average REAR differences (SELF-FIT A - SELF-FIT B) for both ears: 0.07 dB. 95% CI: (-0.88, 0.73).	Yes (CI within +/- 5 dB)
Secondary Effectiveness:
SELF-FIT QuickSIN equivalent to CLINIC-FIT QuickSIN (in-lab)	Average QuickSIN SNR loss differences (CLINIC-FIT - SELF-FIT): -0.38 dB. 95% CI: (-0.94, 0.18).	Yes (CI lower bound > -1.5 dB)
SELF-FIT QuickSIN equivalent to CLINIC-FIT QuickSIN (wear-time field trial)	Average QuickSIN SNR loss differences (CLINIC-FIT - SELF-FIT): -0.06 dB. 95% CI: (-1.47, 1.36).	Yes (CI lower bound > -1.5 dB)
REAR for FINAL-FIT equivalent to REAR for AFTERTRIAL-FIT (wear-time field trial)	Average REAR differences (AFTERTRIAL-FIT - FINAL-FIT) for both ears: -0.22 dB. 95% CI: (-0.87, 0.42).	Yes (CI within +/- 5 dB)
Secondary Reliability:
SELF-FIT QuickSIN (A) equivalent to SELF-FIT QuickSIN (B) (in-lab)	Average QuickSIN SNR loss differences (SELF-FIT A - SELF-FIT B): 0.28 dB. 95% CI: (-0.48, 1.03).	Yes (CI lower bound > -1.5 dB)

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 29 participants were enrolled in the study (13 men, 16 women). 17 subjects withdrew due to poor compliance or personal reasons, meaning the final analysis was likely based on 12 participants.
- Data Provenance: The document does not explicitly state the country of origin but implies a single clinical study setting. It was a prospective study involving participants with perceived mild to moderate hearing impairment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "ground truth" for the test set in this context refers to the CLINIC-FIT measurements. These were established by an "audiology-best-practices hearing aid fitting," which implies fitting by a qualified audiologist. The document does not specify the exact number of audiologists or their years of experience but indicates adherence to "audiology-best-practices."
Adjudication method for the test set:
- The clinical study compared the device's self-fitting method (SELF-FIT) against a clinician-fitted method (CLINIC-FIT). There isn't an explicit "adjudication method" described in the sense of multiple experts reviewing cases. Instead, the "ground truth" (CLINIC-FIT) was established by standard audiological best practices. The comparison was statistical, assessing non-inferiority between the SELF-FIT and CLINIC-FIT results.
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:
- No, a traditional MRMC study comparing human readers with and without AI assistance was not explicitly stated or conducted as described. This study focuses on the effectiveness of a self-fitting hearing aid compared to a clinician-fitted hearing aid, not on AI assistance for human "readers" of medical images or data.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "SELF-FIT" arm of the study represents the performance of the device's self-fitting algorithm without direct human (audiologist) intervention in the fitting process. The user themselves interacts with the app to perform the fitting. However, it's important to note that the user is "in the loop" for the self-fitting process, but an audiologist is not. So while not a fully "algorithm-only" standalone per se, it is standalone clinician-free fitting.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for comparison ("reference standard") was expert-established audiological measurements and patient-reported outcomes, specifically:
  - Real-Ear Aided Response (REAR) based on audiology-best-practices NAL/NL2 prescription, representing an objective acoustic measure.
  - Abbreviated Profile of Hearing Aid Benefit (APHAB) global scores, representing subjective patient outcomes.
  - QuickSIN test results, representing an objective measure of speech recognition in noise.
The sample size for the training set:
- The document does not provide information regarding a specific training set size for the self-fitting algorithm. The focus of this submission is the clinical validation of the device itself, which incorporates the self-fitting technology. The development and training data for the underlying algorithm are not detailed here.
How the ground truth for the training set was established:
- As there is no information on a specific training set in the provided text, there is also no information on how the ground truth for such a set was established. It can be inferred that the NAL-NL2 fitting algorithm, which the device utilizes, is a widely validated and established prescriptive method in audiology, derived from extensive research and clinical data over time, rather than a specific "training set" for this particular device submission.

Summary

{0}------------------------------------------------

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 26, 2023

% Kyle Rose CEO, Rook Quality Systems Rook Quality Systems, Inc. 1155 Mount Vernon Highway, Suite 800 Dunwoody, Georgia 30338

Re: K231550

Trade/Device Name: Sontro® OTC Hearing Aids (AI) Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: September 26, 2023 Received: September 27, 2023

Dear Kyle Rose:

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 appro val 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).

{1}------------------------------------------------

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 820.70) 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 (QS) 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 mediation-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

{2}------------------------------------------------

Indications for Use

See PRA Statement below.

510(k) Number (if known) K2311550

Device Name Sontro® OTC Hearing Aids

Indications for Use (Describe)

The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

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

	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510 K Summary K231550

Preparation Date:	September 21, 2023
-------------------	--------------------

Applicant Name and Address

Company Name:	Soundwave Hearing, LLC
Address:	619 Enterprise Drive, Suite #205Oak Brook, IL 60523

Official Contact:

	Anthony Florek
	President & Founder, Soundwave Hearing, LLC
Telephone:	708-205-7998
Email:	aflorek@hearsoundwave.com

Representative/Consultant

Company:	Rook Quality Systems
Address:	1155 Mount Vernon Hwy, Suite 800Dunwoody, GA 30338

Contact:	Kyle Rose
Telephone:	404-717-9358
Email:	kyle.rose@rookqs.com

Current Device Information

Trade/Proprietary Name	Sontro® Self-Fitting OTC Hearing Aids
Common Device Name	Self-Fitting Wireless Air-Conduction Hearing Aid, Over-the-Counter
Classification Name	Self-Fitting Wireless Air-Conduction Hearing Aid, Over-the-Counter
Regulation Number	21 CFR 874.3325
Product Code(s)	QUH
Classification	Class II
Review Panel	Ear, Nose, and Throat Devices
Predicate Device	Bose SoundControl Hearing Aid (K211008)
Use	Over-the-Counter (OTC)

{4}------------------------------------------------

1. Device Description

2. Intended Use

3. Indications for Use

The Soundwave Hearing Sontro® Self-Fitting OTC 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 use without the assistance of a hearing care professional.

4. Device Information

Per 21 CFR 874.3325, a self-fitting wireless air-conduction hearing aid is a wearable soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling 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 Self-Fitting hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver that can be coupled with domes. Self-fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow users to adjust the volume setting and customize the hearing mode program.

{5}------------------------------------------------

5. Self-Selection Labeling

Self-selection labeling has been included in the Sontro Self-Fitting OTC Hearing Aid's IFU to mitigate the risk of improper self-selection. Summarized, it addresses:

A warning against the use of people younger than 18 years of age. .
Identifying criteria that indicate the user should see a hearing professional. ●
Identifying situations where Sontro Self-Fitting OTC Hearing Aids may help you hear better.
Identifying situations in which Sontro Self-Fitting OTC Hearing Aids may not be suitable ● for the user.
Informing the user that the Sontro Self-Fitting OTC Hearing Aids will not restore normal hearing.
Informing the user that it is good health practice to have hearing loss evaluated by an ● appropriate healthcare professional.

6. Special Controls

The Sontro Self-Fitting OTC Hearing Aids conform to the special controls stated in 21 CFR 874.3325. Soundwave has satisfied these requirements through:

. Clinical Data
Non-Clinical Performance Testing ●
Human Factors Validation ●
Labeling .

7. Comparison of Technological Characteristics

The subject (Sontro Self-Fitting OTC Hearing Aid) and the predicate (Bose SoundControl Hearing Aid) are self-fit hearing aids. The predicate device is considered direct-to-consumer since it was cleared before the finalization of the OTC Hearing Aid Rule; the subject device is an over-the-counter hearing aid. Both the predicate and subject devices are indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in both the predicate and subject hearing aids to allow the user to control and customize the device to the user's hearing needs.

Both devices contain the same technological characteristics:

Self-Fit Hearing Aid ●
Bluetooth
On Device Controls ●

{6}------------------------------------------------

A traditional receiver-in-the-canal (RIC) style form factor ●
Replaceable 312 Battery .
Software App .
Software Platform Compatibility (iOS, Android) .

{7}------------------------------------------------

Substantial Equivalence Technological Comparison Summary:

Table 1 Soundwave Hearing conducted a comprehensy technological comparison between the Sontro® Self-Fiting OTC Hearing Aids and the predicate device (K211008) to facilitate substantial equivalence.

Topic	Subject Device (Sontro®Self- Fitting OTC HearingAid)	Predicate Device(Bose SoundControlHearing Aid)	Discussion of Similarities and Differences
Fitting	Self-FitApply personalized gainsettings based on userin-situ test.Utilizes the validated NAL-NL2 fitting algorithm.	Self-FitLoudness and Fine-Tuning.Utilizes a proprietary fittingalgorithm.	Similarities: Both the predicate and subject devices useproprietary software to program the user's hearing needsto the devices. This self-fitting is done after assessingthe user's hearing loss has been assessed by the softwareDifferences: The subject has three patents for self-fitting, which are used in the software applyingpersonalized gain settings based on a user in-situ testand utilizing the validated NAL-NL2 fittingalgorithm, personalizing the hearing threshold to theuser's unique requirements for hearing amplification.There are no pre-suite hearing thresholds for thesoftware to choose from. The Predicate utilizes aproprietary fitting algorithm, fitting one of severalprograms that best match the user's hearing thresholdwith loudness and fine-tuning by the user.NAL-NL2 is widely used by hearing professionals.Clinical and non-clinical testing supports the subjectdevice's equivalence to the predicate despitetechnological differences. Clinical and non-clinicaltesting performed are detailed in this summary.

{8}------------------------------------------------

Intended userPopulation	18+ Years Old	18+ Years Old	The same: The subject and predicate are intendedfor an 18+ population. This is the intendedpopulation requirement in the OTC hearing AidRule.
Indications forUse	The Soundwave HearingSontro® Self-Fitting OTCHearing Aids are intendedto amplify sound forindividuals 18 years of ageor older with perceivedmild to moderate hearingimpairment. They areadjusted by the user tomeet the user's hearingneeds. The device isintended for use withoutthe assistance of a hearingcare professional.	The Bose SoundControlHearing Aids areintended to amplifysound for adults 18 yearsof age or older withperceived mild tomoderate hearingimpairment. It is adjustedby the user to meet theuser's hearing needs. Nopreprogramming orhearing test is necessary.The device is intendedfor direct-to-consumersales without theassistance of a hearingcare professional.	Similar: The subject Indications for Use is similar to thepredicate, with the appropriate adjustments in accordancewith the OTC Hearing Aid Final Rule.

{9}------------------------------------------------

Technology	Wireless, self-fitting air-conduction hearing aid	Wireless, self-fittingair-conduction hearingaid	The same: The technology between the subject andpredicate is the same. The predicate and subject use(RIC) Receiver in the canal technology.
Housing	Behind the ear hearing aidhousing. Speakers(receiver) and domes thatinsert into each ear separateleft and right ear deviceswith user-control pushbuttons on each unit.Image: Hearing aid diagram with labels for receiver, volume button, open ear dome, microphone, and battery door.	Behind the ear hearing aidhousing. Speakers(receiver) and domes thatinsert into each ear separateleft and right ear deviceswith user-control pushbuttons on each unit.Image: Hearing aid diagram with labels for eartip, speaker, cable, battery door, world volume up button, microphones, hearing aid body, and world volume down button.	Similarities: The subject and predicate design aresimilar; they are BTE with receivers and domes thatinsert into each ear with separate left and right eardevices with user control push buttons on each unit.Differences: The shapes of the subject and predicatedevice housings are slightly different in design.The design differences were tested with a Usabilitystudy. Participants were asked questions relating tothe physical appearance and comfort of the subjectdevice, with a passing result once responses wereevaluated.

{10}------------------------------------------------

Dimensions	Overall, without cable:27.2 mm long (height)13.2 mm wide (depth) X7.8 mm thick (width)	Overall, with cable:33 mm long x 23 mm widex 18 mm thick	Similarities: The subject and the predicate design aresimilar; they are both BTE with receivers and domesthat insert into each ear with separate left and right eardevices with user control push buttons on each unit.Differences: The shapes of the subject and predicatedevice housings are slightly different in design.The design differences were tested with a Usabilitystudy. Participants were asked questions relating tothe physical appearance and comfort of the subjectdevice, with a passing result once responses wereevaluated.
ExpectedServiceLife	2 years	2 years	The same: The expected service life between thesubject and predicate is the same.

{11}------------------------------------------------

OnDeviceControls	Yes	Yes	Similarities: The subject and the predicate design aresimilar, with user-control push buttons on each unit.Differences: The subject's shape and predicate devicecontrols differ slightly in design.The design differences were tested with a Usabilitystudy. Participants were asked questions relating tothe modes and settings of the subject device, with apassing result once responses were evaluated.
--------------------------	-----	-----	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{12}------------------------------------------------

Bluetooth	2.4 GHz	2.4 GHz	The Same: The Bluetooth connection between thesubject and predicate is the same.
Wirelesscommunication	WirelesscommunicationwithhandhelddeviceviaBluetooth	WirelesscommunicationwithhandhelddeviceviaBluetooth	The Same: The wireless communication between thedevice and the handheld device (software) is the samebetween the subject and predicate.
Wirelesscoexistence	The Sontro® OTC HearingAid uses standard 2.4GHzClassic Bluetooth andBluetooth Low Energy(BLE) standards tocommunicate between thehearing aid and the user'sBluetooth-enabled device.From the risk assessment,the temporary loss ofBluetooth communicationfrom interfering RF signalsis appropriately considered anegligible risk, andaccording to AAMI TIR 69,wireless coexistence testingis not required. Note that the	The Bose BMD-0012Hearing Aid uses standard2.4GHz Classic Bluetoothand Bluetooth Low Energy(BLE) standards tocommunicate between thehearing aid and the user'sBluetooth-enabled device.From the risk assessment,the temporary loss ofBluetooth communicationfrom interfering RF signalsis appropriately considereda negligible risk, andaccording to AAMI TIR 69,wireless coexistence testing	The Same: The wireless coexistence between thedevice and the handheld device (software) is the samebetween the subject and predicate. Both use 2.4GHzclassic Bluetooth Low Energy (BLE) standards tocommunicate between the hearing aid and the user'sBluetooth-enabled device.
	is not required. Note that
	the

{13}------------------------------------------------

{14}------------------------------------------------

	interruption of devicecontrol from the Appwould be similar to whenthe user is separated fromtheir Bluetooth-enableddevice.	interruption of devicecontrol from the Appwould be similar to whenthe user is separated fromtheir Bluetooth-enableddevice.
Wireless usercontrolfunctions viamobile app	Volume Control ModesQuiet - Omnidirectionalmic Noise - Adaptive micEntertainment - FixedForward micLeft/Right independentcontrol.	Volume Control ModesFocused, Conversation,Outdoors, Music, TelevisionMic ControlEverywhere, FrontLeft/Right Balance	Similarities: Both the subject and predicate softwarehave the ability for the user to control: Volume,modes, and two microphones. The subject and thepredicate devices allow for omnidirectional andspeech-focus speech options. Omnidirectional andspeech-focused options, both devices work within thesame 120-degree focus.Differences: Subject device modes, microphones, andleft/right balance differ in technological function andnaming.

{15}------------------------------------------------

The Sontro® OTCHearing Aids use twomicrophones on thedevice, which allow fordirectionality. Thisdirectionality operatesspecifically in the threemodes of operation.	The Bose Predicate devicehas two microphones on thedevice, which, during use,may be configured by theuser to be Everywhere (360degrees) or in Front (fixed120 degrees forward)direction of operation.	The additional functionality of the left/right balance ofthe predicate device does not raise questions of safety oreffectiveness for the device.The added Adaptive directionality of the subject devicedoes not raise questions about the safety or effectivenessof the device.Clinical and non-clinical data from a usability studyand data from a clinical validation study support
When the device is inQuiet Mode, themicrophones work omni-directional or 360degrees. While inEntertainment Mode, the		substantial equivalence. Additionally, a usability studywas performed where participants were askedquestions regarding the mode and settings, with apassing result once the results were evaluated.

{16}------------------------------------------------

	Microphones work in afixed forward directionwith a spread of 120degrees. While in NoiseMode, the microphoneswork in a forward cone of120 degrees, but the focusis towards the loudesthuman speech, calledAdaptive Directionality.
Demonstratethat the hearingAid deviceinitiatesBluetoothpairing andBluetoothcontrolfunctionality	Pairing and control with thepaired mobile device.	Pairing and control with thepaired mobile device.	The Same: Both the subject and predicate devices useBluetooth capabilities to pair the devices with thesoftware on the handheld device.
Battery	Hearing Aid with a singlereplaceable 312 zinc-aircell 1.5V, 4 day, 14hr/daybattery coin cell	Hearing Aid with a singlereplaceable 312 zinc-aircell 1.5V, 4 day, 14hr/daybattery coin cell	The Same: Both the subject and the predicate use asingle replaceable 312 zinc-air 1.5V, 4day, 14hr/daybattery, coin cell
Battery Life	Up to four daysassuming 14hr dayusage, depending on thebrand and age ofbatteries	Up to four daysassuming 14hr dayusage, depending on thebrand and age ofbatteries	The Same: Both the subject and the predicate use asingle replaceable 312 zinc-air 1.5V, 4day, 14hr/daybattery, coin cell

{17}------------------------------------------------

{18}------------------------------------------------

Microphones	During use, the earbuds'microphone may beconfigured by the user inthe following modes: Quietmode (Omnidirectional360- degrees degree),Entertainment mode (FixedDirectionality 120-degreeSpeech focused), or NoiseMode (AdaptiveDirectionality 120-degree)	During use, the earbuds'microphone may beconfigured by the user inthe following modes:Everywhere mode(Omnidirectional 360-degree) or Front mode(Fixed Directionality 120-degree Speech focused).	Similarities: The subject and predicate devices allowomnidirectional 360-degree and speech-focus 120-degree options.Differences: The subject device supports an additionaladaptive directional 120-degree noise mode that allowsthe earbuds to determine the most suitable directionalityfor the microphones for the given environment,dynamically changing the directional pattern to reducethe loudest sounds from the rear.The added automatic selection of directionality does notNonclinical data from a usability study and data from aclinical validation study support substantial equivalence.
Device Control	On-Device user controls:- Volume up/down- Mode change- Bluetooth Pairing- Clearing out hearingaid setting	On-Device user controls:- Volume up/down- Mode change- Bluetooth Pairing- Clearing out hearingaid setting	The Same: Both the subject and the predicate use on-device user controls of a rocker switch that allows forthe following: volume up/down, mode change,Bluetooth pairing, and clearing out the hearing aidsetting.
Compression	16-channel widebanddynamic range compression	12-channel widebanddynamic range compression	Similarities: The subject and the predicate usewideband dynamic range compression
			Differences: The subject uses 16 channels, and thepredicate uses 12 channels
			The 4 additional channels on the subject device areadded into the base, mid, and treble and offer similarspectral tilt as the predicate device. The channels areequal divisions of the frequency spectrum from 200 Hzto 8000 Hz. Both the predicate and Sontro® Self-FittingOTC Hearing Aids share the same spectrum. However,the predicate divides this spectrum into 12 sections(channels) of 650 Hz each, and the subject devicedivides the spectrum into 16 sections (channels) or 488Hz. Each channel can be amplified to meet the needs ofthe user with hearing loss within a channel. The 4additional channels do not raise different questions ofsafety or effectiveness.
NoiseReduction	Active noise reduction.Impact noise control.	Active noisereduction. Impactnoise control.	The Same: The subject and the predicate use activenoise reduction with impact noise control.
FeedbackCancellation	Feedback canceller.	Feedback canceller.	The Same: The subject and the predicate use afeedback canceller.
Mobile app	Compatible with iOS andAndroid.	Compatible with iOS andAndroid.	The Same: The subject and the predicate are compatiblewith iOS and Android.
Telephony	No	No	The Same: The subject and the predicate do not usetelephony.
Streaming	No	No	The Same: The subject and the predicate do not usestreaming.
Active NoiseReduction	No	No	The Same: The subject and the predicate do not useactive noise reduction.
Comparison of Subject Modes and Predicate Modes: Quiet vs. Everywhere, microphones pickup 360 Degree sound; Entertainmentvs Front mode, microphones pickup fixed forward sound and Noise mode, microphones pickup dynamic forward sound.
Omnidirectiona1 360 degree	Quiet Mode	Everywhere Mode	Similarities: The subject's Quiet mode, which allowsfor 360-degree sound for pickup around the head of theuser, is similar to the predicates Everywhere mode.Differences: The subject calls this Quiet Mode, and thepredicate calls this Everywhere Mode.
Speech Focus120 degreeFixedDirectionality	Entertainment Mode	Front Mode	Similarities: The subject's Entertainment mode allowsfor 120-degree forward sound pickup while reducingthe sound behind the user, similar to the predicate'sFront mode.Differences: The subject calls this Entertainment Modeand the predicate calls this Front Mode.
Speech Focus120 degreeAdaptiveDirectionality	Noise Mode	N/A	Similarities: Noise mode is not available on thepredicate.Differences: Noise Mode also allows 120 degrees ofsound pick up, similar to the subject's Entertainmentmode. However, the sound pickup will move to aperson speaking without the users being required tomove their heads in that direction. The Subject's Noisemode benefits the user, making interacting with agroup more comfortable rather than swiveling theirhead to face each person speaking as is required by thepredicate device that does not have a Noise mode. Thesubject offers two modes of directionality that the usercan choose from. There is no adverse effect of achoice between two vs. one of the predicate devices.Research and studies show the constant increase ofadaptive directionality in bilateral hearing aids and thebenefit to the user.

{19}------------------------------------------------

{20}------------------------------------------------

{21}------------------------------------------------

{22}------------------------------------------------

Conclusion Technological Comparison

As seen in the comparison table, the subject device have the same design principles and similar design features and performance specifications. The differences in technological characteristics between the subject device, Sontro® Self-Fitting OTC Hearing Aid, and the predicate device (K21108) do not raise different questions of safety and effectiveness. No identified hazard requires additional benefit versus risk analysis supporting substantial equivalence.

{23}------------------------------------------------

8. Substantial Equivalence to Predicate Device

Soundwave Hearing submits the following information to demonstrate that the Sontro® OTC Self-Fitting Hearing Aid is substantially equivalent to the following legally marketed predicate device:

510(k)Number	Predicate Device Name / Manufacturer
K211008	Bose SoundControl Hearing Aid / Bose

The Sontro® Self-Fitting OTC Hearing Aids were evaluated through Clinical and Non-Clinical Performance Testing to demonstrate the substantial equivalence to the predicate device as described in (K211008)

The subject device has the same intended use and similar technological characteristics to the device cleared in K211008.

9. Clinical Data:

For the in-lab session, the primary effectiveness endpoint was assessed by the differences in acoustical real-ear aided response (REAR), a gold-standard measure for the acoustic function of hearing devices for the study population. This endpoint will assess differences between the mean values after two replications of the SELF-FIT method (reliability) and between the SELF-FIT and CLINIC-FIT methods (validity or effectiveness).

For the wear-time trial, the primary outcome measure is a widely used clinical self-report measure of benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB). The APHAB is also a gold-standard, validated assessment of hearing aid benefits relevant to the study population.

Secondary effectiveness endpoints for the laboratory and field trial components were assessed by a standardized measure of speech communication in noise, the QuickSIN test. This is a widely used clinical measure of an adult's ability to understand speech in noise and is closely tied to the wearer's primary complaint of difficulty communicating in noise.

Overall, the study's success was defined by meeting all primary endpoints for the devices' reliability, effectiveness, and safety and the self-fitting process in this study's laboratory and field trial components. Effectiveness outcomes from the SELF-FIT process were equivalent to those of the CLINIC-FIT method in the in-lab session and non-inferior to CLINIC-FIT in the wear-time trial for the study to be considered successful.

{24}------------------------------------------------

Study Flow:

Image /page/24/Figure/1 description: The image shows a flowchart of a study design. The first step is Session 1 (in-lab), which leads to two parallel paths: HAs programmed with Clinician-Fit and HAs programmed with Self-Fit. These two paths are connected by arrows indicating a possible switch between the two. Both paths then lead to Session 2 (in-lab) after a 2-week field trial.

Participants/ Demographics

Twenty-nine patients enrolled in the study, 13 men and 16 women. Seventeen subjects withdrew due to poor compliance or personal reasons. The age of the enrolled patients ranged from 31 to 75 years, on average 58.9 ± 11.7.

able
------	--

	Total	age_min	age_max	age_avg	age_std
Female	16	31	75	60.5	11.6
Male	13	36	70	56.3	11.9
Female + Male	29	31	75	58.9	11.7
by Ethnicity
			N	(%)
White / Caucasian			23	79.4
Hispanic			0	0
Hispanic / Black			0	0
Black / African American			3	10.3
Asian			3	10.3
Total			29	100

{25}------------------------------------------------

Study Endpoints

Primary Effectiveness Endpoints

For the validation component of the immediate in-lab session comparisons, Real-Ear Aided Response (REAR) was measured using both an audiology-best-practices (professional) hearing aid fitting (CLINIC-FIT) and a self-fitting method (SELF-FIT).

. Success criterion is defined as SELF-FIT REAR is equivalent to CLINIC-FIT NAL/NL2 prescription REAR targets based on the average real-ear aided response at 500, 1000, 2000, and 4000 Hz with non-inferiority margins at +/-5 dB (-5 dB ≤ CLINIC-FIT REAR – SELF-FIT REAR ≤ 5 dB).
Real-Ear Aided Response (REAR) was measured twice (A, B) using the SELF-FIT method for the reliability component of the immediate in-lab session comparisons.
The success criterion is the four-frequency average REAR for SELF-FIT B is equivalent to the REAR for SELF-FIT A based on the average real-ear aided response at 500, 1000, 2000, and 4000 Hz with non-inferiority margins at +/-5 dB (-5 dB ≤ SELF-FIT A -- SELF-FIT B ≤ 5 dB).
For the wear-time field trial, the APHAB was measured following an audiology bestpractices hearing aid fitting (CLINIC-FIT) and a self-fitting method (SELF-FIT).
. Success criterion is defined as SELF-FIT APHAB global score is non-inferior to CLINIC-FIT APHAB global scores following completion of the wear-time field trial with a non-inferiority margin of <8.4 (CLINIC-FIT APHABglobal - SELF-FIT APHABglobal ≤ 8.4).

Secondary Effectiveness Endpoints

For the validation component of the immediate in-lab session comparison, aided QuickSIN performance was compared between SELF-FIT and CLINIC-FIT.

. The success criterion is the SELF-FIT QuickSIN speech-recognition threshold in noise (signal-to-noise ratio, SNR-loss) is equivalent to that of CLINIC-FIT with a non-inferiority margin at -1.5 dB (-1.5 dB ≤ CLINIC-FIT - SELF_FIT).
For the reliability component of the immediate in-lab session comparison, QuickSIN performance was measured twice (A, B) using the corresponding SELF-FIT method to assess test-retest reliability.
The success criterion is that QuickSIN thresholds are equivalent for SELF-FIT A and B with non-inferiority margins of ±/-1.5 dB (-1.5 dB ≤ SELF-FIT A - SELF-FIT B ≤ 1.5 dB).

{26}------------------------------------------------

success

For the wear-time field trial, QuickSIN performance was compared between SELF-FIT and CLINIC-FIT after the trial.

Success criterion is defined as SELF-FIT QuickSIN SNR equivalent to CLINIC-FIT QuickSIN SNR following the wear-time field trial completion with a non-inferiority margin at -1.5 dB (-1.5 dB ≤ CLINIC-FIT QuickSIN = SELF-FIT QuickSIN).
Real-Ear Aided Response (REAR) was measured and compared between the initial FIT device and the same device after the trial for the validation component of wear-time field trial comparisons.
The success criterion is four-frequency average REAR for FINAL-FIT is equivalent to the REAR for AFTERTRIAL-FIT based on the average real-ear aided response at 500, 1000, 2000, and 4000 Hz with non-inferiority margins at +/-5 dB (-5 dB ≤ AFTERTRIAL_FIT REAR - FINAL-FIT REAR ≤ 5 dB).

Study Conclusions:

Table 4

N=29 patients	endpoints			NI-criterion		average	95%CI upperbound	95%CI lowerbound	NIestablished
REAR	left andright eartogether	primary endpoint 1	effectiveness	$95% CI lower bound > -5dB$	$CF-(SFA+SFB)/2$	0.17	0.78	-0.44	YES
		primary endpoint 1	reliability	$95% CI upper bound < 5dB$	$SFA-SFB$	-0.07	0.73	-0.88	YES
		secondary endpoint 4	reliability		$SF(Session1)-SF(Session2)$	-0.22	0.42	-0.87	YES
APHAB	GLB	primary endpoint 2	effectiveness	$95% CI upper bound < 8.4$	$CF - SF$	1.93	8.21	-4.35	YES
QickSIN	session 1	secondary endpoint 1	effectiveness	$95% CI lower bound > -1.5 dB$	$QSIN CF-(QSIN SFA+QSIN SFB)/2$	-0.38	0.18	-0.94	YES
		secondary endpoint 2	reliability	$95% CI lower bound > -1.5 dB$	$QSIN SFA-QSIN SFB$	0.28	1.03	-0.48	YES
		secondary endpoint 3	effectiveness	$95% CI lower bound > -1.5 dB$	$avg(QSIN CF)-avg(QSIN SF)$	-0.06	1.36	-1.47	YES

For all 95% confidence interval calculations, the family-wise rate of making a type-I error was controlled. The Bonferroni method was applied. The significance level was adjusted by the number of observations.

For the primary endpoint: In-lab session 1 compares Real-Ear Aided Response (REAR) SELF-FIT REAR with the CLINIC-FIT NAL/NL2 on the average REAR 500, 1000, 2000 and 4000 Hz.

Analvsis results:

Table 4 shows the average of the REAR differences between CLINIC-FIT and SELF-FIT (CLINIC FIT - SELF-FIT). Results are shown for all ears, left ears, and right ears. The point estimate is 0.17 for all ears (left and right combined). The 95% confidence interval for the difference in both ears is (-0.44, 0.78). The non-inferiority margins are at -5 dB and 5 dB.

{27}------------------------------------------------

Conclusion:

The point estimate shows that the average of the differences CLINIC-Fit REAR - SLEF-FIT REAR is within -5 dB and 5 dB. Non-inferiority is demonstrated.

For the primary endpoint: in-lab session 1 compares Real-Ear Aided Response (REAR) SELF-FIT A with SELF-FIT B on the average REAR at 500, 1000, 2000, and 4000 Hz.

Analysis results:

Table 1 shows the averaged differences of the REAR after SELF-FIT-A and SELF-FIT-B. Results are shown for all ears. The point estimate is 0.07 (both ears combined). The 95% confidence interval for the difference in both ears is (-0.88, 0.73). The noninferiority margins are -5 dB and 5 dB.

Conclusion:

Using all ears, SELF-FIT procedure trial A and trial B lead to similar outcomes. Noninferiority is demonstrated.

For the primary endpoint: wear-time field trial session 2 compares the APHAB CLINIC-FIT with SELF-FIT.

Analysis results:

Table 4 shows the averaged differences for the APAHBglobal benefits after two fitting procedures. The point estimate of the effect is 1.93. The 95% confidence interval is (-4.35, 8.21). The non-inferiority margin is 8.4.

Conclusion:

The point estimate favors hearing aid benefits after the CLINIC-FIT procedure. Noninferiority is demonstrated for the in-lab APAHAB SELF-FIT condition when compared with the CLINIC-FIT condition.

For the secondary endpoint: in-lab session 1 compares QuickSIN SELF-FIT with CLINIC-FIT.

Analysis results:

Table 4 shows the averaged differences in Signal-to-Noise (SNR) loss in dB, which were obtained with the QuickSIN test. Results for the two hearing aid fitting procedures are compared, CLINIC-FIT and SELF-FIT. The point estimate of the effect is -0.38. The 95% confidence intervals for the difference is (-0.94. 0.18). The non-inferiority margin is -1.5 dB.

Conclusion:

The point estimate favors the CLINIC-FIT procedure. Non-inferiority is demonstrated for the in-lab SELF-FIT Procedure.

{28}------------------------------------------------

For the secondary endpoint: in-lab session 1 compares QuickSIN SELF-FIT A with SELF-FIT B.

Analysis results:

Table 4 shows the averaged differences in Signal-to-Noise (SNR) loss in dB, which were obtained with the QuickSIN test. Results for two hearing aid fitting procedure are compared, SELF-FIT A and SELF-FIT B. The point estimate of the effect is 0.28, favoring the SELF-FIT B procedure. The 95% confidence intervals for the difference is (-0.48, 1.03). The non-inferiority margin is -1.5.

Conclusion:

SELF-FIT procedure trial A and trial B lead to similar outcomes. Non-inferiority is demonstrated.

For the secondary endpoint: wear-time field trial session 2 compares OuickSIN SELF-FIT with QuickSIN CLINIC-FIT.

Analysis results:

Table 4 shows the difference of the average SNR-loss in dB for the wear-time field trial. Results for the CLINIC-FIT and SELF-FIT are compared. The point estimate of the effect is -0.6, favoring the CLINIC-FIT procedure. The 95% confidence intervals for the difference were (-1.47, 1.36). The non-inferiority margin is -1.5.

Conclusion:

The lower bound of the 95% confidence interval, -1.47, is larger than -1.5 dB. Noninferiority is demonstrated for the SELF-FIT procedure.

For the secondary endpoint: wear-time field trial session 2 compares REAR initial FIT device with the same FIT device after the trial.

Analvsis results:

Table 4 shows the averaged differences in REAR between initial FIT device versus the same FIT device after the trial. The point estimate of the effect is -0.22 (both ears combined). The 95% confidence interval for the difference in both ears was (-0.87, 0.42). The non-inferiority margins are -5 dB and 5dB.

Conclusion:

After the wear-time field session 2, the REAR outcomes after the Initial FIT procedure are similar to the REAR outcomes using the FIT after the trial. Non-inferiority is demonstrated.

Safety Evaluation:

All participants were free from ear infections, pain or discomfort, acute or chronic dizziness, and no sudden onset or rapid deterioration of tinnitus in one or both ears during baseline screening and wearing hearing aids. No adverse events were reported during the clinical trial.

{29}------------------------------------------------

Clinical Data Study Conclusion

The clinical data from this study demonstrates the effectiveness of the self-fitting strategy and satisfies the special controls for the self-fitting hearing aid regulation. Participants experienced noninferior outcomes with self-fitting compared to clinician fitting of the subject device.

10. Non-Clinical Performance Testing

Technological Similarities

The Sontro® Self-Fitting OTC Hearing Aids and predicate device (K211008) share the following technological similarities:

{30}------------------------------------------------

Table 5 Soundwave Hearing conducted Non-Clinical Performance Testing on the Sontry® Self-Fitting OTC Hearing Aids to
provide a reasonable assurance of the safety and effectiv

Test Specifications	Test	Result
IEC 60601-1:2005(Third Edition) + CORR.1:2006 + CORR. 2:2007 +A1:2012ANSI/AAMI ES60601-1:2005 & A1:2012IEC 60601-2-66 2019 Medicalelectrical equipment - Part 2-66:Particular requirements for the basicsafety and essential performance ofhearing aids and hearing aid systems	Electrical Safety:Rating (clause 4.11) Determinationof Accessible parts (clause 5.9.2)Legibility of markings (cl. 7.1.2)Durability of Markings (cl 7.1.3)Leakage/Auxiliary current (cl.8. 7,IEC 60601-2-66, 201.8.7.2.8)Cleaning 11.6.1 (wax removal)Detachment /Mechanical pull test IEC60601-2-66 CL. 201.9.2.102 Drop testIEC 60601-2-66 201.15.3	Conforms, Pass
IEC 60601-1-2 2014 + A1:2020Medical electrical equipment part1-2: General requirements for basicsafety and essential performance-Collateral Standard:Electromagnetic disturbances -requirements and tests	Electromagnetic Compatibility,EMC	Conforms, Pass
CISPR-11- 2015 +A1:2016A2:2019Industrial, scientific, and medicalequipment-Radio-frequencydisturbances characteristics-Limits and methods ofmeasurements	RF Radiated Emissions	Conforms, Pass
Test description for CISPRResults ANSI C63.10:2013	Requirements:	Result
6dB Bandwidth99% BandwidthOutput PowerPower Spectral DensityLow Band EdgeDuty Cycle Correction FactorEIRP	FCC 15C 15.247 ISED RSS-247	All Tests - Confirm/Pass
IEC 61000-4-2	Electrostatic Discharge (ESD)	Conforms/ Pass
IEC 61000-4-3	Radiated Immunity Test	Conforms/ Pass
IEC 61000-4-8	Magnetic Field Immunity	Conforms/ Pass
IEC 60118-7	Electro acoustical testing	Conforms/ Pass
IEC 61000-4-6 - ***The subjectdevices are battery-operated and donot have a connection viacable.	Required for devices connected toa cable, does not apply	N/A
ANSI S3.22	Electro acoustical	Result
Special Control 2 ANSI/CTA2051-2017 and underlying ANSIS3.22-2014	Electroacoustic Characteristics	Conforms/ Pass
ANSI/ASA S3.22-2014 (6.8)	Frequency Response (Gain)	Conforms/ Pass
ANSI/CTA 2051:2017(4.1) withunderlying test method ANSIS3.22:2014 (6.9)	Electro Acoustic -frequencyResponse Bandwidth	Conforms/ Pass
ANSI S3.22:2014 (6.2)	Acoustic Output dB Sound PressureLevel at input 90 db Sound pressureLevel (OSPL 90)	Conforms/ Pass
ANSI S3.22:2014 (6.2)	Maximum Acoustic Output SoundPressure Level Input 90dB SPL(Max OSPL90)	Conforms/ Pass
ANSI S3.22:2014(6.11)	Harmonic Distortion(Output Distortion)	Conforms/ Pass
ANSI S3.22:2014(6.12)	Equivalent Input Noise(EIN)	Conforms/ Pass
ANSI/CTA 2051:2017 (4.8)	Latency	Conforms/ Pass
ANSI S3.22:2014 (6.3)	High Frequency Average OutputSound Pressure Level(HFA OSPL 90)	Conforms/ Pass
ANSI S3.22:2014 (6.5)	High Frequency Average Full onGain (HFA FOG)	Conforms/ Pass
ANSI S3.22:2014 (6.7)	Reference Test Gain (RTG)	Conforms/ Pass
ANSI/CTA 2051:2017 (4.10 –4.17)	Fixed or Level-DependentFrequency Equalization Level- DependentGain/CompressionNoise reduction Signalto Noise RatioEnhancementFeedback ControlPersonalizationCoupling to the EarWireless Connectivity	Conforms/ Pass
Performance Data:Subject Device Designed inConformance with Standards
ISO 14971:2019	Application of Risk managementto Medical Devices	Conforms
IEC 62366-1:2015	Software- Medical DeviceSoftware- Software Life-CycleProcesses	Conforms
IEC 62304:2006+ A1:2015	Software- Medical DeviceSoftware- Software Life-CycleProcesses	Conforms

Spurious Radiated EmissionsHigh Band Edge
IEC 60601	Electromagnetic Immunity
	Result

{31}------------------------------------------------

{32}------------------------------------------------

{33}------------------------------------------------

ANSI/ ASA S3.22 2014 Measurements Comparison

Table 6 To prove substantial equivalence with the predicate device, Soundwave Hearing evaluated the ANSI S3.22 data set from the predicate (K211008) devices' ANSI/ASA 3.2
measurements to establish substantial equivalence in acoustic performance.

Test Standard /Method	Test PurposeDescription	Sontro® Self-Fitting OTC HearingAid (Subject Device)	Bose Hearing Aid (Predicate Device)	Discussion
Special Control 2ANSI/CTA 2051-2017 andunderlying ANSIS3.22-2014	ElectroacousticCharacteristics	Frequency range: 200-8000 Hz.Maximum output (90 dB SPL input):112 dB SPL.Equivalent noise input level: 25dBHFA Full-On-Gain (50 dB SPL input):42 dBLatency: <1ms THD@500Hz: 0.9%THD@ 800Hz: 01.0%THD@1600Hz: 0.4%Per ANSI S3.22-2014 - 2cc couplerHigh Frequency Average (HFA) perANSI S3.22-2014 definition, theaverage of gain or SPL in decibels at1000, 1600 and 2500 Hz.	Frequency range: 200-8000 Hz.Maximum output (90 dB SPL input):113 dB SPL.Equivalent noise input level: 23dBHFA Full-On-Gain (50 dB SPL input):30 dBLatency: 5.5ms THD: 0.5%Per ANSI S3.22-2014 - 2cc couplerHigh Frequency Average (HFA) perANSI S3.22-2014 definition, theaverage of gain or SPL in decibels at1000, 1600 and 2500 Hz.	Similar to the predicate and suitable for theintended user:ANSI/CTA 2051-2017 usesmeasurement methods and 2cc couplerfrom ANSI S3-22, and as such, thefrequency range, maximum output &equivalent noise input level can becompared directly to the predicate device.Total harmonic distortion (THD) andlatency meet the requirements ofANSI/CTA 2051-2017, withrequirements of <5% and <15 ms,respectively. Direct comparison to thepredicate device is not possible as theperformance of the predicate device onthese parameters is not publicly available.The latency and total harmonic distortionmeet the requirements in ANSI/CTA 2051-2017.The subject device is also compliant with21CFR800.30 requirements for OTChearing aids.
ANSI/ASAS3.22- 2014(6.8)	FrequencyResponse(Gain)	Image: Reference Figure 1	Image: Reference Figure 2	Similar to predicate and suitable for theintended user. Adequate for fitting mildto moderate hearing loss as prescribed byNAL-NL2.Specification of hearing aid characteristicand testing both in accordance with ANSIS3.22-2014 supports substantial equivalence.

{34}------------------------------------------------

The subject device is also compliant with21CFR800.30 requirements for OTChearing aids.
ANSI/CTA	Electro Acoustic -	200Hz to 8000Hz	200Hz to 8000Hz	The Same as the predicate
2051:2017(4.1)with underlying testmethod ANSIS3.22:2014 (6.9)	frequency ResponseBandwidth
ANSIS3.22:2014(6.2)	Acoustic OutputdB SoundPressure Level atinput 90 dB Soundpressure Level(OSPL 90)	Image: Maximum Output (OSPL90) graph	Image: Maximum Output (OSPL90) graph	Similar to the predicate and suitable forthe intended user. Adequate for fittingmild to moderate hearing loss asprescribed by NAL-NL2.Specification of hearing aidcharacteristics and testing both inaccordance with ANSI S3.22, supportsubstantial equivalence.
ANSI S3.22:2014(6.2)	Maximum AcousticOutput SoundPressure LevelInput 90dB SPL(Max OSPL90)	112 dB SPL which is less than orequal to 120 dB SPL	113 dB SPL which is less than or equal to120 dB SPL.	Similar to the predicateThe subject is 112dB predicate is 113dB bothare less than or equal to 120dB SPLThe subject device is also compliant with21CFR800.30 requirements for OTChearing aids.
ANSI S3.22:2014(6.11)	HarmonicDistortion(Output Distortion)	Total Harmonic DistortionTHX 500 Hz 0.9%THX 800 Hz 1.0%THX 1600 Hz 0.4%	Less than or equal to 0.5%	Similar to the predicate. Adequate forfitting mild to moderate hearing loss asprescribed by NAL-NL2. Data from aclinical validation study supportsubstantial equivalence.The subject device is also compliantwith 21CFR800.30 requirements forOTC hearing aids.
ANSI S3.22:2014(6.12) perK211008	Equivalent InputNoise(EIN)	25 dB SPL which is less than or equal to32 dB SPL	23 dB SPL which is less than or equalto 32 dB SPL	Similar to the predicate. 2 dB SPLdifference between the subject and thepredicate. Adequate for fitting mild tomoderate hearing loss as prescribed byNAL-NL2. Data from a clinical validationstudy support substantial equivalence.The subject device is also compliantwith 21CFR800.30 requirements forOTC hearing aids.
ANSI/CTA2051:2017 (4.8)perK211008	Latency	<1ms	5.5 ms	Similar to the predicate.Difference: The subject's lower number<1ms vs 5ms may enhance the userexperience; however, the difference between1ms and 5ms may not be able to beperceived by the user.The subject device is also compliant with21CFR800.30 requirements for OTChearing aids.
ANSI S3.22:2014	High Frequency	107 dB SPL	106 dB SPL	Similar to the predicate. Adequate for
(6.3) perK211008	Average OutputSound PressureLevel(HFA OSPL 90)			fitting mild to moderatehearing loss as prescribed by NAL-NL2.Data from a clinical validation study supportssubstantial equivalence.
ANSI S3.22:2014(6.5) perK211008	High FrequencyAverage Full onGain (HFAFOG)	42 dB	30 dB	Similar to the predicate, adequate forfitting mild to moderate.hearing loss as prescribed by NAL-NL2.Difference While the subject FOG valueof 42 dB is greater than the predicate's 30dB this ensures that our device has theability to meet the same gain requirementsonce fitted as the predicate even thoughthe user may not need more amplificationprescribed by NAL-NL2. Data from aclinical validation study supportedsubstantial equivalence.
ANSI S3.22:2014(6.7) perK211008	Reference Test Gain(RTG)	27 dB	29 dB	Similar to the predicate. Adequate forfitting mild to moderate hearing loss asprescribed by NAL-NL2. Data from aclinical validation study supportssubstantial equivalence.
ANSI/CTA2051:2017 (4.104.17) perK211008	Fixed or Level-DependentFrequencyEqualization	level-dependent frequency equalizationthat is adjusted via user controls.	utilize 12-channel wide dynamic rangecompression to make conversationeasier without making loud sounds tooloud.	Similar to the predicate. Adequate forfitting mild to moderate hearing loss asprescribed by NAL-NL2. Data from aclinical validation study supportssubstantial equivalence.
	Level-DependentGain/Compression	utilize 16-channel wide dynamic rangecompression to make conversationeasier without making loud sounds tooloud.	utilize 12-channel wide dynamic rangecompression to make conversationeasier without making loud sounds tooloud.	Similar to the predicate. Adequate forfitting mild to moderate hearing loss asprescribed by NAL-NL2. Data from aclinical validation study supportssubstantial equivalence.
Noise Reduction	make steady noises (like vacuumcleaners, air conditioners, etc.) lessloud.	make steady noises (like vacuumcleaners, air conditioners, etc.) lessloud.	The Same as the predicate.
Signal-to-NoiseRatio Enhancement	have user-selectable directionalmicrophones to emphasize soundsfrom in front, making conversations innoisy places easier.	have user-selectable directionalmicrophones to emphasize soundsfrom in front, making conversations innoisy places easier.	The Same as the predicate.
Feedback Control	reduce feedback (whistling).	reduce feedback (whistling).	The Same as the predicate.
Personalization	are self-tuned by the user either via anapp on a smart device (phone or tablet)Individual hearing thresholds aredetermined via an in situ hearing test topersonalize the amplification settings.	are self-tuned by the user either via anapp on a smart device (phone or tablet)or by using the on-device controls.Individual hearing thresholds are notrequired to personalize theamplification settings.	Similar to the predicate. Adequate forfitting mild to moderate hearing loss asprescribed by NAL-NL2. Data from aclinical validation study supportssubstantial equivalence.
Coupling to the Ear	have a user-adjustable fit for greatercomfort and better sound quality.The ear tip is a soft, conical, open, orclosed tip that rests deep in the earcanal.	have a user-adjustable fit for greatercomfort and better sound quality.The ear tip is a soft, conical, open, orclosed tip that rests deep in the earcanal.	The Same as the predicate.
WirelessConnectivity	use Bluetooth technology to controlthe hearing aids via a paired smartdevice.	use Bluetooth technology to control thehearing aids via a paired smart device.	The Same as the predicate.

{35}------------------------------------------------

{36}------------------------------------------------

{37}------------------------------------------------

{38}------------------------------------------------

{39}------------------------------------------------

Image /page/39/Figure/0 description: The figure shows a frequency response curve, labeled as "Full On Gain (FOG50)". The x-axis represents frequency in Hertz (Hz), ranging from 100 to 10000, while the y-axis represents output in dB SPL, ranging from 0 to 60. The curve shows a relatively flat response between 100 Hz and 1000 Hz, followed by a peak around 2000 Hz, and then a drop-off at higher frequencies. The text at the bottom indicates that the curve represents the nominal frequency response as measured in a 2 cc coupler.

Figure 1 Nominal Frequency Response Curve for Sontro Self-FittingOTC Hearing Aids Full on Gain (FOG50)

Image /page/39/Figure/2 description: The figure shows a plot of the full-on gain (FOG50) in decibels (dB) as a function of frequency in Hertz (Hz). The x-axis represents the frequency, ranging from 100 Hz to 10000 Hz. The y-axis represents the gain, ranging from 0 dB to 50 dB. The plot shows that the gain is around 23 dB at 100 Hz, increases to around 30 dB at 300 Hz, remains relatively constant until 2000 Hz, and then increases to a peak of around 35 dB at 3000 Hz before decreasing to around 16 dB at 10000 Hz.

Image /page/39/Figure/3 description: The image shows the title of a figure. The title is "Figure 2 Nominal Frequency Response Curve for Predicate (K211008) Full On Gain (FOG50)". The title indicates that the figure is a graph that shows the frequency response of a predicate with a specific code and gain setting. The figure is labeled as Figure 2.

Image /page/39/Figure/4 description: This image is a graph titled "Maximum Output (OSPL90)". The graph shows the output in dB SPL on the y-axis and the frequency in Hz on the x-axis. The curve on the graph shows that the maximum output is around 110 dB SPL at a frequency of 100 Hz, and then it gradually decreases to around 90 dB SPL at a frequency of 10000 Hz. The graph is labeled as "Nominal OSPL curve as measured in a 2 cc coupler".

Image /page/39/Figure/5 description: The image contains the word "Aid" in a serif font. The word is presented in a simple, straightforward manner. The text is centrally aligned and occupies a significant portion of the image.

Image /page/39/Figure/6 description: The image is a graph titled "Maximum Output (OSPL90)". The x-axis is labeled "Frequency (Hz)" and ranges from 100 to 10000. The y-axis is labeled "Output (dB SPL)" and ranges from 70 to 120. The graph shows a curve that starts at approximately 100 dB SPL at 100 Hz, rises to approximately 107 dB SPL, remains relatively flat until it reaches 1000 Hz, then peaks at approximately 113 dB SPL before decreasing to approximately 92 dB SPL at 10000 Hz.

Figure 4 Nominal OSPL Curve, Maximum Output OSPL90 for Predicate (K211008)

{40}------------------------------------------------

Usability Testing

Soundwave conducted a human factors validation test of the Sontro® Self-Fitting OTC Hearing Aids. The usability testing included 17 untrained participants representing the intended user population (individuals 18 years of age or older with perceived mild to moderate hearing impairment).

The test was performed in the participant's homes, representing the intended use environment of the Soundwave Hearing Sontro® OTC Hearing Aids. Each participant performed hands-on use scenarios and knowledge tasks with the Soundwave Hearing Sontro Self-Fitting OTC Hearing Aids, including the otoTune® app, packaging, accessories, and user documentation. All interaction points between the user and the device were tested to validate user needs and the operation of each device component and user interface as a whole.

After the use scenarios and knowledge tasks, the online tests asked open-ended questions to collect participants' subjective assessments of the use safety and usability by the moderator. The Zoom interviews (during covid) focused on topics of particular interest, ease of use of the otoTune app to customize the Sontro Self-Fitting Hearing Aids, and the validation of the user's improved hearing with the Sontro Self-Fitting Hearing Aids. Users were asked to assess their ability to hear more clearly in noisy environments and assess making adjustments to volume, the equalizer, and noise reduction settings in the Control screen.

Data for the usability test was collected through observational data by 1 Zoom call per participant to observe the participant set up the device. Knowledge task data, 2 follow-up user interviews to assess the ability of the user to operate the device with the user manual, quick start guide, labeling on the device itself, and changing and replacing ear domes, wax guards, and receivers. The interviewer recorded this observational and knowledge task data during the testing to include use problems and use errors.

Participants were given four online tests to record and evaluate the knowledge tasks, points of interaction and operational device components. The results of the human factors validation testing were analyzed qualitatively to determine if the design of the device (or the labeling or user training) needs to be modified to reduce the use-related risks to acceptable levels.

Usability Testing indicates that the subject device and app are able to be used correctly for the intended user, uses, and environment.

11. Non-Inferiority Conclusion

The Sontro® Self-Fitting OTC Hearing Aids have the same intended use and fundamental technology as the predicate, Bose SoundControl Hearing Aid (K211008). Similarly, as its predicate, the Sontro® OTC Hearing Aids are a user-fitted wireless air-conduction hearing aid K231550

{41}------------------------------------------------

intended for use by individuals 18 years or older with perceived mild to moderate hearing impairment.

The differences in technological characteristics between the subject device, Sontro Self-Fitting OTC Hearing Aid, and the predicate device (K21108) do not raise different questions of how safe and effective they are under specified use conditions. No identified hazard requires additional benefit versus risk analysis supporting non-inferiority.

Clinical testing results indicate that the data support our hypothesis that the device's self-fit procedure is non-inferior to the predicate for the hearing aid fitting in a clinical setting for patients with mild to moderate hearing loss. The clinical study showed:

Real-Ear Aided Responses compare after the self-fit procedure and the fitting of the hearing aid by a certified audiologist. Non-inferiority for the differences of the fitting procedures has been established.

The global APHAB scores and the outcomes of the QuickSIN test show that Sontro Self-Fitting OTC Hearing Aids provide benefits in hearing for mild to moderate hearing-impaired individuals. Non-inferiority for the differences of the fitting procedures has been established.

The outcomes of the QuickSIN test are similar after the self-fit procedure and the fitting of the hearing aid by a certified audiologist. Non-inferiority for the differences of the fitting procedures has been established.

No adverse incidences during the use of the hearing aids have been reported during the study.

Sontro Self-Fitting OTC Hearing Aids. as well as the predicate device, are safe and provide use benefits (effective). The self-fit procedure for both devices is non-inferior to the fitting by a certified audiologist.

Non-clinical performance testing based on the ANSI/ASA S3.22 standards demonstrated the Sontro Self-Fitting OTC Hearing Aids are acoustically comparable to the predicate device(K211008). Non-clinical testing has been conducted to confirm that variations in both form factor and software do not compromise the established safety and effectiveness benchmarks set by the predicate device (K211008).

The subject device Sontro Self-Fitting OTC Hearing Aids conformed to/passed all the nonclinical tests and standard evaluations for Electrical Safety, Electromagnetic Compatibility, CISPR RF Radiated Emissions, CISPR ANSI C63.10:2013, Electromagnetic Immunity, Electro acoustical per ANSI S-322 and was designed in conformance with ISO 14971:2019, IEC 62366-1:2015, IEC 62304:2006+ A1:2015.

Results from the usability test indicated that Soundwave Hearing's Sontro® Self-Fitting OTC Hearing Aids Hearing and otoTune app are able to be used correctly by the intended users under the anticipated condition of use. No identified hazard requires additional benefit versus risk analysis in support of non-inferiority for the Sontro Self-Fitting OTC Hearing Aids. K231550

{42}------------------------------------------------

In summary, the combined evidence from technology equivalence assessments, clinical testing, non-clinical performance testing, EMC testing, and results from usability testing supports the conclusion that the Sontro Self-Fitting OTC Hearing Aids are non-inferior to the predicate device (K211008).

Conclusion

The Sontro® Self-Fitting OTC Hearing Aids are substantially equivalent in intended use and fundamental scientific technology to the Bose SoundControl Hearing Aids (K211008). The Sontro Self-Fitting OTC Hearing Aids are considered as safe and effective as the predicate device for their intended use when used in accordance with the otoTune® app and the Instructions for Use as Self-Fitting OTC Hearing Aids, QUH.

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.