The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones.

The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.

Device Description

The All-Day Clear Slim ADCS1 hearing aid and All-Day Clear ADC1 hearing aid are self-fitting air-conduction hearing aids. The ADCS1 and ADC1 hearing aids are nearly identical except for minor design differences. The hearing aid system consists of hearing aids for left and right ears, charging case, charging cable with USB-A and USB-C connector, wall plug, a set of eartips (small, medium, and large sizes), cleaning brush, carrying case (for ADCS1 hearing aids alone), and wax guards. The ADCS1 and ADC1 hearing aids are indicated for over-the-counter use.

The end user can self-fit the hearing aid by downloading the All-Day Clear App to their Android or Apple iOS device, pairing the hearing aids to the App, and following a series of guided onboarding steps:

Instructions on how to wear the hearing aids
Creation of a sound profile by listening to sample audio in which the user selects parameters for volume and sound clarity
Selection of sound balance

Once the hearing aids have been set up with a sound profile, the App can continue to be used as a remote control of the hearing aids. For example, the end users can use the App to change the volume or mute the hearing aid microphones (together or independently), switch between different hearing aid sound modes, adjust the volume of a streamed signal, adjust equalizer and wind noise control, and read out the status of the hearing aid charge level.

The ADCS1 and ADC1 hearing aid system provides an alternative optional method of fitting the device by letting the end users purchase "In-Clinic Care Package", where they can have a licensed hearing care professional fit their hearing aids using professional fitting software called "All-Day Clear Fitting Software." All-Day Clear Fitting Software is a component of Sonova's TrueFit 5.3 or higher fitting software which can only be used by a licensed hearing care professional. In both scenarios, the end users can use the App as a remote control of the hearing aid.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Endpoint)	Non-inferiority Margin	Reported Device Performance (Self-Fit vs. Pro-Fit)	Conclusion on Acceptance Criteria Met?
Primary Effectiveness Endpoint:
APHAB Global Benefit Score (Self-Fit)	Not more than 12.5% below Pro-Fit	Adjusted mean treatment difference: 0.6% (95% CI: -2.919% to 4.742%) (after outlier exclusion)	Met (Lower bound > -12.5%)
Secondary Effectiveness Endpoint:
QuickSiN Benefit Score (Self-Fit)	-1.8 dB or higher	Adjusted mean treatment difference: 0.103 dB SNR (95% CI: -0.867 to 1.074 dB SNR) (Period 1 data)	Met (Lower bound > -1.8 dB)
Safety Endpoint:	(Implicit: No serious adverse events or unacceptable adverse events)	One non-serious treatment-emergent adverse event (ear canal occlusion, not device-related). No serious adverse events.	Met

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Clinical Study: 44 participants (enrolled). Due to early discontinuations and outlier exclusion, analysis for effectiveness endpoints was based on varying numbers:
  - APHAB: 40 participants (after excluding 2 outliers from the original 42 for Period 1 analysis).
  - QuickSiN: 40 participants (Period 1 data analysis).
- Human Factors/Usability Study: 30 participants (15 patients, 15 caregivers).
Data Provenance: Retrospective from clinical study performed with "HelloGO" hearing aid, which is stated to have identical hardware and almost identical firmware to the subject devices (ADCS1, ADC1). The human factors study was prospective, conducted specifically for the ADCS1/ADC1. The country of origin for the clinical study is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The clinical study did not involve AI assistance, therefore "ground truth" was established through direct measurement of human hearing abilities and perceptions using standardized audiological tests (APHAB and QuickSiN) with both self-fitted and professionally fitted devices.
Professionally Fit Devices: Implies fitting by audiologists or hearing care professionals, but the specific number or qualifications of these professionals for establishing the "ground truth" (the professional fit as a comparator) are not detailed beyond "professional fitting method."

4. Adjudication Method for the Test Set

Clinical Study (Effectiveness Endpoints): Not applicable in the sense of expert adjudication of a device's output. The study design involved direct comparison of patient-reported outcomes (APHAB) and objective speech-in-noise testing (QuickSiN) under two different fitting conditions (self-fit vs. professional fit). The "ground truth" for the benefit scores was derived directly from participant responses and test results.
Human Factors/Usability Study: "Study staff systematically assessed device usage to identify problems that were encountered by participants, including use errors and close calls during participant performance." This suggests observation and recording of events, rather than a formal expert adjudication of discrete findings.

5. 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, an MRMC comparative effectiveness study was not done. This study focuses on the effectiveness of a self-fitting hearing aid compared to a professionally fitted one, not on AI assistance for human readers/clinicians.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense, the "self-fitting" method can be considered a standalone performance of the algorithm (as implemented in the app) plus the user's interaction, without a hearing care professional in the loop for the fitting process itself. The study compared this "self-fitted" performance to a "professionally fitted" performance.

7. The Type of Ground Truth Used

Clinical Study (Effectiveness):
- Patient-Reported Outcomes: Abbreviated Profile of Hearing Aid Benefit (APHAB) global benefit score.
- Objective Audiological Measure: Quick Speech-in-Noise (QuickSiN) test benefit score.
- The "ground truth" for comparison was the outcome achieved with a professionally derived fitting.
Safety: Tabulation of adverse events and serious adverse events.
Human Factors/Usability: Observed use errors and close calls in a simulated environment, and participant feedback.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the clinical study parameters. The study design is a comparative effectiveness study between two fitting methods (self-fit and professional fit) for the hearing aid itself. The "self-fitting algorithm" embedded in the app would have had its own development and possible internal training process, but details of this are not provided in the context of this FDA summary.
The human factors study did not involve a training set; it was a usability validation.

9. How the Ground Truth for the Training Set Was Established

As a training set for the specific self-fitting algorithm is not detailed, the method for establishing its "ground truth" (e.g., what data it was trained on to achieve optimal fitting) is not provided in this document. The clinical study established ground truth for effectiveness comparison by using a professionally fitted condition as a benchmark.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

June 16, 2023

Sonova AG % Philip Won Associate Hymann, Phelps, & McNamara, P.C. 700 13th Street N.W Suite 1200 Washington DC, District of Columbia 20005

Re: K230538

Trade/Device Name: All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QUH Dated: May 19, 2023 Received: May 19, 2023

Dear Philip Won:

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 (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 located 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.

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

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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/cdrh-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 Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K230538

Device Name All-Day Clear ADC1 hearing aid

Indications for Use (Describe)

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

	Owner-Time Home (STTR 201.301-306)
	Owner-Time Home (STTR 201.301-306)

| | 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.

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}------------------------------------------------

Indications for Use

510(k) Number (if known) K230538

Device Name All-Day Clear Slim ADCS1 hearing aid

Indications for Use (Describe)

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.

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.

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."

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

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: JUNE 16, 2023

SUBMITTER:

Sonova AG 28 Laubisruetistrasse Staefa, Zurich 8712 Switzerland

PRIMARY CONTACT PERSON:

Jongho "Philip" Won Associate Hyman, Phelps, & McNamara, P.C. Phone: 202-577-4132 Email: PWon@hpm.com

SECONDARY CONTACT PERSON:

Nelson Hu Senior Regulatory Systems Analyst Phone: +1 226-338-1048 Email: Nelson.Hu@sonova.com

DEVICE NAME AND CLASSIFICATION:

TRADE NAME:	All-Day Clear Slim ADCS1 hearing aidAll-Day Clear ADC1 hearing aid
COMMON/USUAL NAME:	OTC Self-fitting Hearing Aid
CLASSIFICATION NAMES:	Self-fitting Air-Conduction Hearing Aid
REGULATION NUMBER:	21 C.F.R. § 874.3325
PRODUCT CODE:	QUH
CLASSIFICATION:	Class II
REVIEW PANEL:	Ear, Nose, and Throat

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

PREDICATE DEVICE:

Bose SoundControl Hearing Aid (K211008)

DEVICE DESCRIPTION:

Instructions on how to wear the hearing aids ●
Creation of a sound profile by listening to sample audio in which the user selects . parameters for volume and sound clarity
Selection of sound balance .

INTENDED USE:

All-Day Clear Slim ADCS1 hearing aid: All-Day Clear Slim hearing aids are intended for individuals 18 years and older with perceived mild to moderate hearing loss.

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

All-Day Clear ADC1 hearing aid: All-Day Clear hearing aids are intended for individuals 18 years and older with perceived mild to moderate hearing loss.

INDICATIONS FOR USE:

All-Day Clear Slim ADCS1 hearing aid: The All-Day Clear Slim hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear Slim hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to setup and/or adjust All-Day Clear Slim hearing aids through Android and Apple iOS smartphones.

All-Day Clear ADC1 hearing aid: The All-Day Clear hearing aids are intended for individuals 18 years or older with perceived mild to moderate hearing loss. The intended use of the All-Day Clear hearing aids is to amplify and transmit sound to the ears and hereby compensate for hearing loss. The hearing aids must only be used by the intended person. They should not be used by any other person as they could damage hearing. The charging case is intended to charge the battery of the rechargeable hearing aids. The All-Day Clear App is intended for individuals 18 years or older, to set-up and/or adjust All-Day Clear hearing aids through Android and Apple iOS smartphones.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the subject device (ADCS1 and ADC1 hearing aids) and the predicate device (Bose SoundControl Hearing Aids) are self-fitting hearing aids indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs.

Both devices are receiver-in-canal (RIC) hearing aids designed for all-day wear. While there are some technical differences between the Sonova and Bose devices they do not introduce different questions of safety or effectiveness. The key similarities and differences between the Sonova ADCS1/ADC1 hearing aids and the Bose SoundControl hearing aids are summarized in Table 1.

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

	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
ProductCode	QUH	QUH	QDD	Different.The product codeQUH reflects theOTC status of thedevice, and theproduct code QDDreflects a restricteddirect-to-consumerdevice was in useprior to the passage ofthe OTC hearing aidrule.

Table 1. Comparison of technical characteristics of Sonova ADCS1/ADC1 hearing aids and Bose SoundControl hearing aids.

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

	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
IntendedUse	All-Day Clear Slimhearing aids areintended for individuals18 years and older withperceived mild tomoderate hearing loss.	All-Day Clear hearingaids are intended forindividuals 18 years andolder with perceivedmild to moderatehearing loss.	Bose SoundControlHearing Aids are apair of user-fittedwireless air conductionhearing aids intendedfor use by individuals18 years and olderwith perceived mild tomoderate hearingimpairment.	Identical.
	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
IndicationsFor Use	The All-Day Clear Slimhearing aids are intended forindividuals 18 years or olderwith perceived mild tomoderate hearing loss. Theintended use of the All-DayClear Slim hearing aids is toamplify and transmit soundto the ears and herebycompensate for hearing loss.The hearing aids must onlybe used by the intendedperson. They should not beused by any other person asthey could damage hearing.The charging case isintended to charge thebattery of the rechargeablehearing aids. The All-DayClear App is intended forindividuals 18 years orolder, to set-up and/or adjustAll-Day Clear Slim hearingaids through Android andApple iOS smartphones.	The All-Day Clear hearingaids are intended forindividuals 18 years or olderwith perceived mild tomoderate hearing loss. Theintended use of the All-DayClear hearing aids is toamplify and transmit soundto the ears and herebycompensate for hearing loss.The hearing aids must onlybe used by the intendedperson. They should not beused by any other person asthey could damage hearing.The charging case isintended to charge thebattery of the rechargeablehearing aids. The All-DayClear App is intended forindividuals 18 years orolder, to set-up and/or adjustAll-Day Clear hearing aidsthrough Android and AppleiOS smartphones.	The Bose SoundControl™Hearing Aids are intendedto amplify sound forindividuals 18 years of ageor older with perceivedmild to moderate hearingimpairment. It is adjustedby the user to meet theuser's hearing needs. Nopre-programming orhearing test is necessary.The device is intended fordirect-to-consumer saleand use without theassistance of a hearingcare professional.	Comparable topredicate. Bothdevices are indicatedfor individuals 18 yearsand older withperceived mild tomoderate hearing loss.The ADCS1/ADC1hearing aids areintended for the over-the-counter use.
	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
Devicedescription	Sonova ADCS1 hearingaids amplify andtransmit sound to theears and therebycompensate forperceived mild tomoderate hearing loss.The users can self-fit theADCS1 hearing aidsusing the All-Day ClearApp by selecting aSound Profile in theApp.	Sonova ADC1 hearingaids amplify andtransmit sound to theears and therebycompensate forperceived mild tomoderate hearing loss.The users can self-fit theADC1 hearing aidsusing the All-Day ClearApp by selecting aSound Profile in theApp.	Bose SoundControlhearing aid is awearable soundamplifying device thatis intended tocompensate forimpaired hearing.This technologyintegrates user inputwith a self-fittingstrategy and enablesusers to independentlyderive and customizetheir hearing aid fittingand settings. Thedevice consists of thehardware, software,the Bose Hear app, andaccessories.	Comparable topredicate. Both thesubject and predicatedevices include hearingaid hardware, software,and accessories.
	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
Battery	Rechargeable battery	Rechargeable battery	Disposable size 312zinc-air battery	Different. A differenttype of battery doesnot raise differentquestions of safetyand effectiveness.The battery safetytests demonstratedthat the subject deviceis as safe andeffective as thepredicate deviceswith respect to thebattery.
	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
MaxOSPL90	109 dB SPL	110 dB SPL	113 dB SPL	Comparable topredicate.The subject devicehas a lower MaxOSPL90 than thepredicate device,indicating that it is assafe as the predicatedevice. A one or fourdB SPL difference ofthe Max OSPL90compared to thepredicate device doesnot raise differentquestions ofeffectiveness asdemonstrated by theclinical study.
	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
High-frequencyaverage(HFA)OSPL90	103 dB SPL	106 dB SPL	106 dB SPL	Comparable topredicate.Devices areequivalent in safetyby having an equal orlower value. A one orthree dB SPLdifference comparedto the predicatedevice does not raisedifferent questions ofeffectiveness asdemonstrated by theclinical study.

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

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

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

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

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

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

	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
HFA full ongain (FOG)	29 dB	29 dB	30 dB	Comparable topredicate.Devices areequivalent in safetyby having an equal orlower value. A onedB SPL differencecompared to thepredicate device doesnot raise differentquestions ofeffectiveness asdemonstrated by theclinical study.

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

	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
Referencetest gain(RTG)	26 dB	29 dB	29 dB	Comparable topredicate.Devices areequivalent in safetyby having an equal orlower value. A one orthree dB SPLdifference comparedto the predicatedevice does not raisedifferent questions ofeffectiveness asdemonstrated by theclinical study.

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

	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
Frequencyrange	100 – 8,000 Hz	100 – 5,000 Hz **This is the bandwidthmeasured with themethod as specified inANSI/CTA-2051:2017.When measured withthe method as specifiedin ANSI/ASA S3.22-2014, the bandwidth forADC1 hearing aids is100 – 10,000 Hz.	200 – 8,000 Hz	Comparable topredicate.Values meet the sameANSI/CTA-2051:2017 standardfor “Standard Band”device.
	Sonova ADCS1Hearing Aids (SubjectDevice)	Sonova ADC1 HearingAids (Subject Device)	Bose SoundControlHearing Aids(K211008, PredicateDevice)	Discussion
HarmonicDistortion	THD @ 500 Hz: 0.5%THD @ 800 Hz: 0.5%THD @ 1,600 Hz: 1.0%THD @ 3,200 Hz: 1.0%	THD @ 500 Hz: 1.0%THD @ 800 Hz: 1.0%THD @ 1,600 Hz: 1.0%THD @ 3,200 Hz: 0.5%	< 1%	Comparable topredicate.Values are eitherequal or do notexceed 1%. TheANSI/ASA S3.22-2014 specification forHarmonic Distortionallows themanufacturer atolerance of 3% forthis measurement.Thus, our values arecomparable.
Equivalentinput noise(EIN)	19 dB SPL	19 dB SPL	< 27 dB SPL	Comparable topredicate.Values do not exceed27 dB SPL.

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

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

PERFORMANCE DATA:

Summary of Non-Clinical Tests

Sonova AG conducted a series of non-clinical performance testing to demonstrate that the Sonova ADCS1/ADC1 Hearing Aids are as safe and effective as the Bose SoundControl Hearing Aid. The results are summarized in Table 2 below. Note that the same set of non-clinical performance testing was reported for the predicate Bose SoundControl hearing aid (K211008).

Test	Test Standard / Method	Result
Electrical Safety	IEC-60601-1: 2005 + Corr.1: 2006 + Corr.2.:2008 + A1:2012 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 IEC 60601-2-66:2019	Pass
ElectromagneticCompatibility(EMC)	IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION ANSI C63.19-2019 IEC 60118-13:2020 FCC: CFR 47, Part 15, Subpart B, (10-1-19) & ICES-003 Issue 6 (Updated 2019-04)	Fail (*see the note below)
RF Testing	FCC 1093 47 CFR Part 2 FCC 47 CFR Part 15.249, RSS-210 Issue 9	Pass
Biocompatibility	ISO 10993-1:2018	Pass
Human Factorsand UsabilityEngineering	The summative human factors study was performed following the FDA guidance document entitled "Applying Human Factors and Usability Engineering to Medical Devices."	Pass

Table 2. Non-Clinical performance tests for the ADCS1/ADC1 Hearing Aids.

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

Test	Test Standard / Method	Result
Software	• ISO 14971:2019 Medical Devices–Application of Risk Management	Pass
ElectroacousticPerformance	• ANSI/CTA-2051:2017	Pass

The ADCS1 hearing aid samples for electrostatic discharge (ESD) immunity failed for the direct contact discharge at ±8kV. The ADC1 hearing aid samples for ESD immunity failed for the air discharge at ±15kV and for the direct contact discharge at ±8kV. The sample devices became inoperable after these ESD exposures. Per the EMC/ESD testing. the ADCS1 and ADC1 hearing aids do not pose a safety risk and they are as safe and effective as the predicate devices because (1) except for these testing conditions, the ADCS1 and ADC1 hearing aids passed the rest of the tests per IEC 60601-1-2, (2) none of the failed sample devices showed signs of visible damage, melting, fire, or explosion, (3) a type of ESD protection circuitry is implemented in the ADCS1/ADC1 hearing aids and (4) the supplied LiION batteries for the ADCS1 and ADC1 hearing aids meet the battery standards UN38.3 and UL1642. Finally, the labeling instructs users to return any non-functional or damaged devices for service.

Summary of Human Factors / Usability Tests

The primary objective of the human factors usability validation study was to investigate whether the ADCS1/ADC1 hearing aids and the companion mobile App could be used as intended by adult patients and caregivers in a simulated use environment. This study determined if first-time end users could appropriately use the ADCS1/ADC1 device design, labeling, instructional materials, mobile phone application, and packaging such that use errors or difficulties that could result in harm were avoided. This study investigated the respective root causes and potential outcomes for use errors that occurred or almost occurred (i.e., close call).

The intended demographic for this study was adult patients with perceived mild to moderate hearing loss and caregivers of patients with perceived mild to moderate hearing loss. Thirty participants were enrolled in the study-fifteen patients and fifteen caregivers. Participants were asked to complete tasks in a simulated use environment associated with self-selecting, setting up, and using the ADCS1/ADC1 hearing aids. During the study session, study staff systematically assessed device usage to identify problems that were encountered by participants, including use errors and close calls during participant performance. Use-error evaluations of the device included both

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

objective (performance-based) and subjective (user-feedback) evaluations of success for completing the tasks identified as critical for appropriate and safe use.

The results of this human factors usability validation study indicate effective selfselection of the ADCS1/ADC1 hearing aids by inexperienced adults with perceived mild to moderate hearing loss and inexperienced caregivers of adults with perceived mild to moderate hearing loss. All 30 participants were able to use the package information to decide if the device was appropriate or not appropriate for them or the person they care for to use. This study also demonstrated the safe use of the ADCS1/ADC1 hearing aids for inexperienced adults with perceived mild to moderate hearing loss and inexperienced caregivers of adults with perceived mild to moderate hearing loss.

Summary of Clinical Tests

Background: Sonova AG performed the clinical study to demonstrate the effectiveness of the self-fitting strategy for adults with mild to moderate hearing impairment compared to a professionally derived fitting. Sonova AG used the device "HelloGO" hearing aid for this clinical study. All Day Clear Slim is a re-branded HelloGo device with identical hardware and almost identical firmware. Based on the comparison and evaluation of the devices with respect to the technical, material, labeling, and clinical characteristics, it is reasonable to conclude that the three devices (ADCS1, ADC1, and HelloGO) are equivalent and there are no significant differences regarding safety and effectiveness of the devices.

Study Endpoints:

The primary effectiveness endpoint: Non-inferiority of the Abbreviated Profile of . Hearing Aid Benefit (APHAB) global benefit score for self-fit the devices versus professionally fit devices.
The secondary effectiveness endpoint: Non-inferiority of the Quick Speech-in-● Noise (QuickSiN) test benefit score for self-fit devices versus professionally fit devices.
The safety endpoint: A tabulation of all adverse events (AEs) and serious adverse . events (SAEs) during the study.
Exploratory endpoints:
- o Wearing comfort questionnaire
- 0 Net promoter score
- o Real ear aided response (REAR)

Participants: A total of 44 participants were enrolled. There were 19 females enrolled in the study and 25 males, and the average age was 68 years with a range between 22 and 80 years. Thirty-four participants (77.27%) were new users of hearing devices, and 10

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

participants (22.7%) were current owners of hearing aids. Figure 1 shows average pure tone air conduction thresholds for the study participants.

Image /page/21/Figure/1 description: The figure is a graph comparing the hearing thresholds of the left and right ears across different frequencies. The x-axis represents frequency in Hertz (Hz), ranging from 250 to 8000 Hz. The y-axis represents the threshold in decibels Hearing Level (dB HL), ranging from 0 to 80. The graph shows two lines, one for the left ear and one for the right ear, with data points indicating the hearing threshold at each frequency, and the hearing threshold decreases as the frequency increases.

FIGURE 1. AVERAGE PURE TONE AIR CONDUCTION THRESHOLDS FOR THE STUDY PARTICIPANTS

Study Design: A double-blind, cross-over study as shown in Figure 2.

Image /page/21/Figure/4 description: This image shows a flowchart of a study with approximately 44 participants. The participants go through self-fitting and professional fitting, followed by a washout period of 1-5 days. After the washout, 23 participants receive self-fit treatment for 14 days, while 21 participants receive professional fit treatment for 14 days. The participants then switch treatments for another 14 days before visit 4, where APHAB and QuickSIN are performed, and the study concludes.

FIGURE 2. STUDY FLOW DIAGRAM SUMMARIZING THE SEQUENCE OF EVENTS FOR EACH PARTICIPANT.

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

The 44 participants were randomized into one of the following two treatment sequence groups for the cross-over study.

23 participants for Professional Fit / Self-Fit (A/B) .
21 participants for Self-Fit / Professional Fit (B/A) .

Four participants were early discontinued (two in each group). These participants did not introduce bias that would affect the validity of the results for the following reasons:

Two of the four early-discontinued participants never began a home trial, therefore no aided data was collected for either fitting method.
Participant #21 completed period 1 using the professionally fit method, while participant #22 completed period 1 using the self-fitting method. Neither participant continued with the second fitting, therefore only period 1 aided data was collected. The aided APHAB and OuickSiN scores for period 1 for each participant were similar, and because there was one representative from each group, the scores offset each other and did not affect the validity of the results.

At visit 1, all participants were fit with two sets of devices: one set was professionally fit and one set was self-fit. Participants downloaded the App at this visit and were given the opportunity to self-adjust the devices according to their preferences. Participants were not given any devices at this time. Rather, a wash-out period of 1-5 days occurred and as participants returned for visit 2. Participants were blinded as to which device they were given for the first home trial.

Participants returned for visit 3 after a 2-week home trial period and completed the APHAB. QuickSiN and a blinding assessment. Upon completion of these assessments, the first set of devices was collected, and the second set of devices was dispensed as per the treatment schedule. Following another two-week home trial, participants returned for visit 4 to complete the assessments.

Results:

Primary Effectiveness Endpoint: APHAB Global Benefit Score

The APHAB global benefit score is defined as the aided APHAB global scores (one each for self-fit versus professional fit) subtracted from the unaided/baseline APHAB global scores. A higher score indicates greater improvement with the devices. It was hypothesized that the benefit of the self-fitting method would be non-inferior to the benefit of the professional fitting method if the mean APHAB global benefit score for the self-fitting method was no more than 12.5% below the mean APHAB global benefit score

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

for the professional fit method. This hypothesis was tested using a mixed model with the following variables.

The dependent variable: APHAB global benefit score ●
Fixed effects: Treatment sequence, period, and treatment .
Random effect: participants .
Covariate: First-period baseline performance ●

The adjusted mean treatment difference from the mixed model was 0.5%, with a 95% confidence interval ranging from -3.4% to 4.4%. While this finding supports the claim of non-inferior APHAB outcomes with the self-fitting relative to the professional-fitting, the model also found a significant effect of treatment sequence. To further explore this potential effect, an additional analysis of Period 1 data only was conducted, in accordance with the Statistical Analysis plan. The Period 1 analysis was initially inconclusive, as the adjusted mean treatment difference from the mixed model was 0.024 with a 95% confidence interval ranging from -17.937 to -1.252. Non-inferiority could not be concluded because the lower bound of the confidence interval (CI) was less than the non-inferiority margin of -12.5%. Upon further inspection of the APHAB data, however, two outliers were identified. Both were in the Professionally Fit group in Period 1, and were identified as outliers for their unusually high unaided scores for the subscale "Background Noise" (scores of 87 and 91). Given that the mean score for this sub-scale was 44.09302 and SD was 18.1368, these two participants were excluded because their score was greater than 2 SDs above the mean. This indicates that these two subjects experienced unusually high degrees of perceived difficulty understanding speech in background noise in the baseline condition. These high unaided scores impacted their resulting aided benefit, which we believe led to the inconclusive result for non-inferiority when analyzing Period 1 data for the APHAB.

Upon reanalysis excluding these two outliers, the adjusted mean treatment difference for the APHAB Global Benefit score was 0.6%, with a 95% confidence interval ranging from -2.919 to 4.742. and the treatment sequence term is no longer significant. Therefore, non-inferiority can be concluded because the lower bound of this confidence interval is greater than the non-inferiority margin.

Figure 3 shows the scatter plot of the APHAB Global Benefit scores for 40 participants. The dotted line shows one-to-one correspondence.

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

Image /page/24/Figure/0 description: The image is a scatter plot that compares the global benefit score of self-fit and prof-fit. The x-axis represents the global benefit score for prof-fit, while the y-axis represents the global benefit score for self-fit. The data points are scattered around a diagonal line, which indicates a positive correlation between the two scores. Most of the data points are clustered between 0.0 and 0.2 on both axes.

FIGURE 3. SCATTER PLOT OF APHAB GLOBAL BENEFIT SCORES FOR 40 PARTICIPANTS.

Secondary Effectiveness Endpoint: QuickSiN Benefit Score

The QuickSiN test is an objective measure of speech intelligibility in a noisy environment. The QuickSiN is performed in both unaided and aided conditions. The dB SNR (Signal to Noise Ratio) loss is expressed by the SNR at which the participant correctly repeats 50% of the words presented. A lower dB SNR score indicates better speech perception in noise. The QuickSiN benefit score is defined as the aided QuickSiN scores (one each for self-fit versus professional fit) subtracted from the unaided/baseline QuickSiN scores. It was hypothesized that the benefit of the self-fitting method would be non-inferior to the benefit of the professional fitting method if the difference was -1.8 dB or higher. This hypothesis was tested using a mixed model.

The adjusted mean treatment difference from the mixed model was 0.046 dB SNR, with a 95% confidence interval ranging from -0.597 to 0.688 dB SNR. Although the treatment sequence term in this model was not significant, an analysis of Period 1 data only was conducted to remain consistent with the approach applied to the APHAB data. Re-analysis using Period 1 data only resulted in an adjusted mean treatment difference of 0.103 dB SNR, with a 95% confidence interval ranging from -0.867 to 1.074. Noninferiority was concluded by observing that the lower bound of this confidence

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

interval was greater than the non-inferiority margin of -1.8 dB SNR. Figure 4 shows the scatter plot of the QuickSiN benefit scores for 40 participants.

Image /page/25/Figure/1 description: This image is a scatter plot that compares QuickSiN Benefit scores for Self-Fit and Prof-Fit. The x-axis represents the QuickSiN Benefit score for Prof-Fit, while the y-axis represents the QuickSiN Benefit score for Self-Fit. The data points are scattered across the plot, with a dotted line indicating a trend. The x and y axis range from -4 to 4.

FIGURE 4. SCATTER PLOT OF QUICKSIN BENEFIT SCORES FOR 40 PARTICIPANTS.

The safety endpoint: A tabulation of all adverse events and serious adverse events during the clinical study.

Finally, it is important to note that the design of the study allowed each subject to serve as his or her own control. The full analysis of APHAB data from both periods relied on within-subjects comparisons to draw the conclusion that the self-fitting approach was non-inferior relative to the professional-fitting approach. When examining Period 1 data alone, the analysis is, by definition, a between-subjects analysis. In this analysis, a difference between the group beginning one fitting method relative to the other may suggest inferior performance, irrespective of whether the self-fitting method was truly inferior for the sample in the population on a within-subjects level. Outcomes with hearing aids can vary widely (evident in the standard deviation of the primary endpoint for both treatments). That the group beginning with one treatment had a significantly higher mean benefit than the group beginning with the other treatment is not necessarily a reflection of a treatment difference. It is, instead, likely a manifestation of

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

the variability in hearing aid outcomes. Further evidence of this may be seen in the Period 2 data. Period 2 results are almost a perfect mirror of the Period 1 outcomes, demonstrating that subjects did not experience a treatment difference during the course of the study. Had a true carryover effect been present, a more likely pattern would be to see a different level of benefit in the Period 2 data for one group than the other; this pattern was not seen in our data.

There was one treatment-emergent adverse event reported in the self-fit group. Subject 01 reported an ear canal occlusion in between Visit 2 and Visit 3. During the first home trial, while fitted with the self-fit hearing aid, the participant used over-thecounter ear drops. The ear drops were reportedly for cerumen removal, but the participant appeared to use the drops incorrectly, which resulted in an inflamed tympanic membrane. This event was not serious and required no action to be taken. The participant was able to complete the study. There were no serious adverse events. The clinical study demonstrated that the ADCS1/ADC1 hearing aids are as safe as the predicate Bose SoundControl hearing aids.

Exploratory Endpoints

Wearing comfort questionnaire: Of 44 enrolled participants, 93.2% (N = 41) . completed a questionnaire regarding the physical comfort of the device. Overall, the majority of participants rated all questions with a response of "Comfortable" or "Very Comfortable." Sixty-four percent of the Professional Fit participants in Period 1 rated the wearing comfort of the BTE piece as either comfortable or very comfortable, and 58% of the Self-Fit participants in Period 1 rated it as comfortable or very comfortable. This is similar to both Period 2 and overall data.
Net promoter score: Of 44 enrolled participants, 93.2% (N = 41) completed a Net ● Promotor Score questionnaire. This questionnaire asked participants to rate, on a scale of 0 to 10 (10 is best), how likely they would be to recommend the devices to a friend or family member. A rating of 9 or 10 constitutes a "promotor." In summary, 26.1% of participants were categorized as "promotors." Period 1 data shows that 32% of the Professional Fit participants and 21% of the Self Fit participants were considered "promotors". These percentages were reversed for the overall NPS data which indicates that those who started as promotors remained promotors throughout the study.
Real Ear Aided Response (REAR): Of 44 enrolled participants, 97.7% (N = 43) ● completed REAR measurements. In summary, the average response at 1000. 1600, and 2500 Hz was approximately 3 dB lower for the self-fit frequency response compared to the professionally fit response as shown in Figure 5 below.

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

Image /page/27/Figure/0 description: The image is a boxplot comparing the mean output level in dB SPL for two different fitting methods, ProFit and SelfFit, across varying input levels in dB. The input levels are 50, 65, 75, and 85 dB. For each input level, the ProFit method generally has a slightly higher mean output level than the SelfFit method. The mean output level increases as the input level increases for both fitting methods.

FIGURE 5 REAL EAR-AIDED RESPONSE FOR PROFESSIONAL FIT VS SELF-FIT

In summary, an analysis of Period 1 data shows non-inferior results for self-fitting on the QuickSiN, as well as consistent results between self-fitting and professional fitting on two exploratory endpoints (physical comfort and Net Promotor Score). While the Period 1 analysis of APHAB did not support non-inferiority, it was observed that two study participants with extreme baseline scores for the "Background Noise" subscale of the APHAB were both assigned to begin the study with the professional fitting. A reanalysis of the APHAB results from both Period 1 and 2 that excluded these participants supported non-inferiority of the self-fitting relative to professional fitting while removing the previously significant term for treatment sequence, confirming that the significant treatment sequence finding in the original analysis was highly sensitive to the presence of the two outliers. Taken together, these findings support the noninferiority of the self-fitting relative to the professional fitting.

CONCLUSION:

Sonova AG demonstrates that the All-Day Clear Slim hearing aids and the All-Day Clear hearing aids are as safe and effective as the predicate Bose SoundControl Hearing Aid. The Sonova ADCS1/ADC1 hearing aids have the same intended use and similar

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

indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Sonova ADCS1/ADC1 hearing aids and its predicate device raise no different questions of safety and effectiveness when the Sonova ADCS/ADC1 is compared to the predicate device. Therefore, the Sonova ADCS1/ADC1 hearing aids are substantially equivalent to the Bose SoundControl Hearing Aid.

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.