The Concha Sol 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. No pre-programming or hearing test is necessary. The device is intended for use without the assistance of a hearing care professional.

Device Description

The Concha Sol OTC Hearing Aids (Model CL-1001) are receiver-in-the ear, self-fitting, wireless air conduction hearing aids (§ 874.3325) intended to amplify sounds in the environment for adult users who have a perceived mild-to-moderate hearing loss. The hearing aids include Ear Tips, Carry Case and the Concha Labs mobile application. The device is indicated for over-the-counter sale (product code QUH) and 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. The mobile application contains a self-fitting software known as Soundscope, an innovative software that uses the NAL-NL2 programming formula used globally by hearing aid manufacturers. The hearing profile/personalization system in the Concha Sol Hearing Aid assesses the individual's hearing levels across a frequency spectrum in order to generate and customize the device's amplification specific to their hearing needs. The self-fitting software also assesses the individual's hearing preferences to help fine-tune the device's amplification. In addition to hearing aid functionality for environmental and directive listening; the hearing aids can also be used for telephony and streaming audio from a Bluetooth® compliant mobile device. The hearing aids are powered using Zinc Air size 312 cell batteries.

AI/ML Overview

The Concha Sol Hearing Aids (CL-1001) were evaluated for their effectiveness and safety through a clinical study. The study objective was to assess the performance and clinical effectiveness of the self-fitting hearing aid using two distinct fitting methods: SELF-FIT (user-fitted with the Concha Labs App) and CLIN-FIT (clinically fitted by a hearing care professional).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Endpoint)	Target Performance (Margin)	Reported Device Performance (Concha Sol SELF-FIT vs. CLIN-FIT)	Outcome
Effectiveness:
Quick Speech-in-Noise (QuickSIN)	SELF-FIT outcomes comparable to CLIN-FIT within a margin of 1.8 dB for QuickSIN benefit	Not explicitly stated as numerical difference or statistical test result but indicated as "comparable performance"	Met: "For both assessed endpoints, the study results indicated comparable performance and satisfaction outcomes as revealed from clinical data as compared to the same hearing aid fit by a clinician." This implies the 1.8 dB margin was met or that the difference was not statistically significant beyond this margin.
Abbreviated Profile of Hearing Aid Benefit (APHAB)	SELF-FIT outcomes comparable to CLIN-FIT within a margin of 9.9 for APHAB	Not explicitly stated as numerical difference or statistical test result but indicated as "comparable performance"	Met: "For both assessed endpoints, the study results indicated comparable performance and satisfaction outcomes as revealed from clinical data as compared to the same hearing aid fit by a clinician." This implies the 9.9 margin was met or that the difference was not statistically significant beyond this margin.
Safety:	No device-related or other adverse events	No device-related or other adverse events observed	Met: "No device-related or other adverse events were observed over the course of the study. Also, no health-related issues due to device fit or discomfort were observed, and no device failures leading to potential safety issues were observed."

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

Sample Size: 21 participants (13 men, 8 women).
Data Provenance: The document does not explicitly state the country of origin. The study design ("within-subject, randomized, crossover study design of the clinical investigation") suggests it was a prospective clinical study.

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

Number of Experts: The document details the "CLIN-FIT" method, which involved fitting by a "hearing care professional." It does not specify the number of individual hearing care professionals involved or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the traditional sense for these endpoints. The study compared two fitting methods (self-fit vs. clinician-fit) within the same subjects, using standardized objective (QuickSIN) and subjective (APHAB) outcome measures. The "ground truth" for the CLIN-FIT condition was established by the hearing care professional's fitting, which was then used as a reference for comparison.

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

No, a MRMC comparative effectiveness study was not explicitly described. The study design was a "within-subject, randomized, crossover study" to compare the performance of the Concha Sol device under two different fitting methods (SELF-FIT vs. CLIN-FIT). While human readers (users and a clinician) were involved in the fitting process and perception, it was not framed as an MRMC study comparing interpretations of diagnostic cases.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this was not a diagnostic AI study. The "AI" component would be the self-fitting software (Soundscope), which the users interact with directly. The comparison was between user-driven fitting and clinician-driven fitting of the same device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not explicitly described for clinical effectiveness. The clinical study inherently involved human feedback and interaction (either by the user for SELF-FIT or by the clinician for CLIN-FIT). The Soundscope software's performance was evaluated as part of the overall device system in conjunction with human use. Electroacoustic testing provided standalone performance metrics for the hardware and general sound processing, but not specifically for the self-fitting algorithm's clinical outcomes without human interaction.

7. Type of Ground Truth Used

Ground Truth: The study used the performance of the device when fitted by a hearing care professional (CLIN-FIT) as a reference "ground truth" for comparison against the user's self-fitting (SELF-FIT) results. This is an expert-derived benchmark using established clinical practices.
- QuickSIN: Objective measure of speech communication in noise.
- APHAB: Subjective measure of hearing impairment and benefit in daily life.
- Safety: Directly observed adverse events and health-related issues.

8. Sample Size for the Training Set

Not Applicable / Not Provided: The document describes a clinical validation study for the Concha Sol device. It does not mention a separate "training set" for the self-fitting algorithm. The Soundscope software uses the NAL-NL2 programming formula, which is an established, globally used, prescriptive target rule for hearing aid fitting, implying its development and "training" occurred much earlier and separately from this device-specific validation.

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

Not Applicable / Not Provided: As noted above, the document does not describe a training set for the self-fitting algorithm within the context of this submission. The NAL-NL2 (National Acoustic Laboratories - Nonlinear 2) formula, which the Soundscope technology utilizes, is a well-established prescriptive method in audiology. Its "ground truth" (i.e., its derivation and validation) would stem from extensive research, clinical trials, and epidemiological data in hearing science involving human perception, speech intelligibility, and comfort over many years, conducted by the National Acoustic Laboratories (Australia) and other research institutions. This is a foundational audiological principle rather than a training set specifically for this device's algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

March 15, 2024

Concha Labs % Joseph Burke Regulatory Consultant for Concha Labs Joseph Burke Consulting Inc. 16 Rebekah Lane Sutton, Massachusetts 01590

Re: K233747

Trade/Device Name: Concha Sol Hearing Aids (CL-1001) Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: February 12, 2024 Received: February 12, 2024

Dear Joseph Burke:

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

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

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

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Your device is also subject to, among other requirements, the Quality System (QS) 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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

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Indications for Use

Submission Number (if known)

K233747

Device Name

Concha Sol Hearing Aids (CL-1001)

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)

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510(k)#: K233747	510(k) Summary	Prepared 12 Feb 202-
1. CONTACT DETAILS		21 CFR 807.92 (a)(1)
Concha Labs55 East 3rd AvenueSan Mateo, CA, 94401Company Contact: Carlos BullockOfficial Correspondent: Joseph Burke
2. DEVICE NAME		21 CFR 807.92 (a)(2)
Name of Device: Concha Sol OTC Hearing Aids (CL-1001)Common Name: Self-fitting OTC Hearing AidClassification Name: Self-fitting Air Conduction Hearing AidRegulation: 21 CFR §874.3325Regulatory Class: IIProduct Code: QUHReview Panel: Ear, Nose and Throat Devices

3. LEGALLY MARKETED PREDICATE DEVICE

Predicate #: K211008 Predicate Trade Name: Bose SoundControl Hearing Aids Product Code: QDD

DEVICE DESCRIPTION SUMMARY 4.

The mobile application contains a self-fitting software known as Soundscope, an innovative software that uses the NAL-NL2 programming formula used globally by hearing aid manufacturers. The hearing profile/personalization system in the Concha Sol Hearing Aid assesses the individual's hearing levels across a frequency spectrum in order to generate and customize the device's amplification specific to their hearing needs. The self-fitting software also assesses the individual's hearing preferences to help fine-tune the device's amplification. In addition to hearing aid functionality for environmental and directive listening; the hearing aids can also be used for telephony and streaming audio from a Bluetooth® compliant mobile device. The hearing aids are powered using Zinc Air size 312 cell batteries.

Prepared 12 Feb 2024

55 East 3rd Avenue San Mateo, CA 94401

21 CFR 807.92 (a)(3)

21 CFR 807.92 (a)(4)

510(k) Sur

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5. INTENDED USE

21 CFR 807.92 (a)(5)

21 CFR 807.92 (a)(6)

6. INDICATIONS FOR USE COMPARISON

The indications for use of the subject device are "The Concha Sol 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. No preprogramming or hearing test is necessary. The device is intended for use without the assistance of a hearing care professional."

A comparison of the indications for use of the Concha Sol Hearing Aids are similar to those of the predicate device (Bose SoundControl Hearing Aid (K211008)); with the exception of the point of sale. The Bose SoundControl is described as a Direct to Consumer (DTC) device (Product code QDD); whereas the Concha Sol Hearing Aids are indicated for Over the Counter (OTC) sale (Product code QUH). The Concha Sol is also in compliance with all elements of the OTC Hearing Aid Final Rule, as well as compliant with OTC requirements for labeling.

7. TECHNOLOGICAL COMPARISON

The technological characteristics of the Concha Sol Hearing Aids are similar to those of the predicate device Bose SoundControl Hearing AID (K211008). The table below provides a comparison of the subject and predicate devices. A thorough review of these products revealed the devices are equivalent from a technological perspective.

	Subject Device	Predicate	Discussion
Device Trade Name	Concha SolHearing Aids	Bose SoundControlHearing Aid
510k Number	K233747	K211008
Product code	QUH	QDD	Similar to the predicate withexception of the point of sale:OTC (Concha) vs. DTC(Bose). Subject devicecomplies with OTC hearingaid requirements outlined in21 CFR 800.30.
Regulation number	21 CFR 874.3325	21 CFR 874.3325	Same as predicate
Regulation name	Self-fitting airconduction hearingaid	Self-fitting air conductionhearing aid	Same as predicate
Intended Use	The Concha SolHearing Aid isintended to amplifysound for individualswith perceived mild tomoderate hearingimpairment.	The Bose SoundControlHearing Aid is intended toamplify sound forindividuals with perceivedmild to moderate hearingimpairment.	Same as predicate

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Image /page/5/Picture/0 description: The image shows a yellow symbol that appears to be a stylized representation of a flame or a drop of liquid with a jagged edge at the top. The symbol is enclosed by two curved lines on either side, resembling parentheses or sound waves. The overall design is simple and abstract, with a focus on the central flame-like shape.

Indications for Use	The Concha SolHearing Aid isintended to amplifysound for individuals18 years of age orolder with perceivedmild to moderatehearing impairment.They are adjusted bythe user to meet theuser's hearing needs.No pre-programmingor hearing test isnecessary. Thedevice is intended foruse without theassistance of ahearing careprofessional.	The Bose SoundControlHearing Aids are intendedto amplify sound forindividuals 18 years ofage or older withperceived mild tomoderate hearingimpairment. They areadjusted by the user tomeet the user's hearingneeds. No pre-programming or hearingtest is necessary. Thedevice is intended fordirect-to-consumer saleand use without theassistance of a hearingcare professional.	The subject device hassimilar Indications for Useas the predicate device,with the appropriateadjustment in accordancewith the OTC Hearing AidFinal Rule.
Battery	Single use 312 ZincAir Batteries	Single use 312 Zinc AirBatteries	Same as predicate

	Subject Device	Primary Predicate	Discussion
Device Trade Name	Concha Sol OTCHearing Aids	Bose SoundControlHearing Aid
Housing	Behind The Ear (BTE)Receiver In Canal(RIC) hearing aidhousing. Separate leftand right ear unitswith a separate EarTip for each unit. Onthe device, 'RockerSwitch' used tocontrol volume.Mobile devicestreaming and phoneaudio via Bluetooth.	Behind The Ear (BTE)Receiver In Canal (RIC)hearing aid housing.Separate left and rightear units with a separateEar Tip for each unit. Ondevice, 'Rocker Switch'used to control volume.	Devices are similar withonly slight dimensionaldifferences.
Input signalcompression	Wide dynamic rangecompression	Wide dynamic rangecompression	Same as predicate
Microphones	Microphones may,during use, beconfigured by theuser in omni-directional ordirectional modes	Microphones may,during use, beconfigured by the user inomni-directional ordirectional modes	Same as predicate
Battery Lifetime	Per CTA 2051 (4.1-4.17)Battery life of 5 days,13 hours per day	Per CTA 2051 (4.1-4.7)Battery life of 4 days, 14hours per day	The battery life is similar tothat of the predicate anddifferences raise no newquestions of safety andeffectiveness.

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Image /page/6/Picture/0 description: The image shows the logo for Concha Labs. The logo consists of a yellow abstract symbol on the left, followed by the words "CONCHA LABS" in a bold, sans-serif font. The text is in a dark gray or black color. The logo appears to be clean and modern.

	Subject Device	Primary Predicate	Discussion / Results
Device Trade Name	Concha Sol OTCHearing Aids	BoseSoundControlHearing Aid
Self-fitting method	Subject device uses aproprietarySoundscopetechnology, with initialgain parametersbased on NAL- NL2.	Loudness and Fine-tuning app-basedControllers. Utilizesa proprietary fittingmethod.	Performance testingevaluated these differencesin technology and the resultssupport substantialequivalence.
Mobile App	Mobile application ona smart device (phoneor tablet) with an iOSoperating platform.	Mobile application on asmart device (phone ortablet) with either iOS orAndroid platforms.	Similar to predicate butcurrently subject device onlyuses iOS operating platform.This does not raise newissues regardingsafety and effectiveness.
Streaming /Telephony	Subject deviceprovides audiostreaming andtelephone viaBluetooth.	N/A	Predicate does not includethe features. They do notraise new issues of safety oreffectiveness Performancetesting evaluated thedifferences in technologyand the support substantialequivalence.
Electro-AcousticCharacteristics	Subject Device	Primary Predicate	Discussion
	Concha Sol OTCHearing Aids	Bose SoundControlHearing Aid	Compliance to $800.30
Latency Clause	6.7 ms	Less than or equal to 15ms	Both devices meetrequirements
Frequencyresponse	<200Hz ->10000 Hz	<200Hz -> 8000 Hz	Both devices meetrequirements
Input DistortionClause	1.20%	5%	Both devices meetrequirements
Equivalent InputNoise (EIN)	18.6 dB SPL	< 27 dB SPL	Both devices meetrequirements
HarmonicDistortion	Less than or equal to1%	Less than or equal to 1%	Same as predicateand meetrequirements
Max OSPL90	115.2 dB SPL	113 dB SPL	Both devices meetrequirements
HFA OSPL90	113 dB SPL	106 dB SPL	Both devices areadequate for fitting mildto moderate hearingloss as prescribed byNAL- NL2.

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HFA FOG	48.4 dB	30 dB	Subject device willprovide more high-frequency average full-on gain (HFA-FOG) andtherefore moreamplification for softsound inputs. Nospecific gain limit wasidentified or required inthe Final OTC HearingAid rule. Although thisvalue is higher than thepredicate BoseSoundControl device by18.4 dB, the subjectdevice features outputlimiting (WDRC).
RTG	36.3 dB	29 dB	The subject device isadequate for fitting mildto moderate hearingloss as prescribed byNAL-NL2. The data froma clinical validationstudy supports thesubstantial equivalencebetween the subjectdevice and thepredicate.

These findings, along with the results of performance testing, indicate that the Concha Sol Hearings Aids are substantially equivalent to the Bose SoundControl (K211008) from a technological perspective.

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8. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS 21 CFR 807.92 (b)

Biocompatibility

Compliance to the testing requirements for a limited duration (less than 24 hrs.), direct skin contact device was based on the FDA recognized consensus standards ISO 10993-1 and FDA quidance on application of said standard to medical devices for U.S. market. ISO 10993-1: Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a Risk Management Process and FDAs 2020 final guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility assessment outcomes were deemed adequate based on intended use.

Shelf Life/Sterility

The non-sterile hearing aid is maintained by the user by wiping with a dry, soft cloth on the outside surface of the housing; a provided brush assists in removal of visible debris from vents and ear tip. Device is intended to have a 2 year service life while none of the device components are subject to degradation that could impact an 'endpoint' of shelf-life.

Electrical Safety:

The Concha Sol Hearing Aid electrical circuitry was tested extensively to verify design criteria and performance with respect to electrical system specifications and properties in support of its safety and effectiveness (IEC 60601-1:2012). The Concha Sol Hearing Aid was tested in finished form and passed testing for battery life, and runtime (ANSI S3.22:2014).

60601

The Concha Sol Hearing Aid was tested per the requirements of IEC 60601-1:2012, standard for medical electrical equipment: General requirements on basic safety and essential performance to provide reasonable assurance of the basic safety and essential performance of the device.

The Concha Sol Hearing Aid was also tested per the requirements of IEC 60601-2-66:2019, standard for medical electrical equipment: Practical requirements for basic safety and essential performance of Hearing Instruments and Hearing Instrument Systems to provide reasonable assurance of the basic safety and performance of the device.

EMC and Wireless

The Concha Sol Hearing Aid was tested per the requirements of IEC 60601-1-2, 2014, AMD1:2020 standard for medical electrical equipment: General requirements on basic safety and essential performance on Electromagnetic Compatibility to provide reasonable assurance that the device performs all/remain functions that are within its specified range of operation in concert with its intended use.

Electroacoustic Testing

The Concha Sol Hearing Aid electroacoustic design was tested extensively to verify design criteria and performance with respect to electroacoustic system specifications and properties in support of its safety and effectiveness. The Concha Sol Hearing Aid passed the following tests not limited to: Monaural/Binaural Directions, Battery Life, and ANSI S3.22/ASA S3.22-2014 and CTA 2051 related tests. Electro Acoustic Measurement Verification was completed and found in compliance with §800.30 requirements and similar to the predicate.

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Battery Life Verification

Testing demonstrated that Concha Sol Hearing Aid device meets ANSIS3.22/CTA 2051 standard for manufacturer to report the estimated battery life values requirements and IEC 60601-2-66:2019.

Mechanical Testing

The Concha Sol Hearing Aid mechanical design was tested extensively to verify its design criteria and performance with respect to the mechanical system specifications and properties in support of reasonable assurance of safety and effectiveness. The Concha Sol Hearing Aid, including Ear Tips were tested in finished form and passed Packaging and Environmental testing.

Transportation

Simulations of transport of the Concha Sol Hearing Aids' packaging to remain intact during testing per ASTM 599, ASTM 5276 and ASTM 4169 DC-13. All requirements were met.

Human Factors/Usability

Concha Labs assessed its hearing aid for usability and human factors to provide reasonable assurance of the usability engineering process and to mitigate risks caused by usability problems per its intended use. The company performed a series of three iterative usability evaluations (Formative Studies 1, 2 and 3) during the development of the hearing aid and companion Concha Labs mobile app. Participants met the device criteria for an intended user. Key findings and device/labeling modifications were implemented to the user interface design in response to the studies.

Summative Human factors were validated across two primary studies.

Human factors/usability validation test in which 15 representative users attempted all critical and essential tasks in the context of realistic use scenarios;
· Self-selection validation study in which 27 potential consumers determined if the hearing aid was appropriate for their needs based on pre-screening information (e.g., outside package labeling, etc.).

The validation of human factors/usability aspects of the device included 15 representative users ranging in age from 25 – 76 (median age of 70) and included 10 females/5 males with 2/3 of all participants aged 60 and above. Five participants self-described a mild hearing loss and 10 indicated a moderate with 9/15 indicating no prior hearing aid experience.

Assessment to determine if potential users can make a correct self-selection decision (suitability of Concha Sol for their personal use) based on their perceived level of hearing loss, presence or absence of contraindications after only having access to review Concha Labs website or product packaqing.

After analysis of data per pre-specified 'success' outcomes it was determined that the Concha Sol Hearing Aid and Concha app are able to be used correctly by the intended users under the anticipated condition of use.

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Clinical Performance Testing

The objective of the within-subject, randomized, crossover study design of the clinical investigation was to assess and evaluate the performance and clinical effectiveness of the Concha Sol self-fitting hearing aid, according to two distinct fitting methods. The first method involved users fitting the hearing aid devices themselves by relying exclusively on the provided iQS smartphone application (Concha Labs App), without any support from a hearing care professional (SELF-FIT). The second method used the same hearing devices, but it was clinically fitted by a hearing care professional following industry best practices (CLIN-FIT).

STUDY PARTICIPANT DEMOGRAPHICS

Demographically, the study participants included a representative mix of female/male, age, and prior experience with hearing aids.

SEX	NUMBER
MEN	13
WOMEN	8
AGE,	YEARS
MEAN (SD)	66.2
MEDIAN (IQR)	73.0
HA EXPERIENCE	NUMBER
INEXPERIENCED USERS	17
EXPERIENCED USERS	4

Additionally, the 'indications for use' of the Concha Sol Hearing Aid stated the intended users have a perceived mild to moderate hearing loss. As part of the study protocol, audiometric measures were taken and indicated that their hearing was consistent with that target population (perceived mild-to-moderate) hearing status.

STUDY ENDPOINTS AND SUCCESS CRITERIA

Effectiveness:

A standardized measure of speech communication in noise, the Quick Speech-in-Noise (QuickSIN) Test was used as the primary effectiveness endpoint. A secondary effectiveness endpoint, the Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to evaluate the effect on hearing impairment or benefit in daily life. Note that for each intervention, endpoints were measured at the end of the two-week take-home field trial.

Following previous studies investigating the effectiveness of self-fitting relative to clinician-fitting (including the predicate device study; Sabin et al., 2020), a margin of 1.8 dB was defined for the QuickSIN benefit, and a margin of 9.9 for the APHAB. For the clinical study to be deemed successful, the SELF-FIT method needs to yield outcomes (namely QuickSIN and APHAB scores) which are comparable to the CLIN-FIT method. For both assessed endpoints, the study results indicated comparable performance and satisfaction outcomes as revealed from clinical data as compared to the same hearing aid fit by a clinician.

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Safety:

No device-related or other adverse events were observed over the course of the study. Also, no health-related issues due to device fit or discomfort were observed, and no device failures leading to potential safety issues were observed. These results support that the subject hearing aids are safe for its intended users.

The clinical study has demonstrated that the Concha Sol hearing aids are comparably safe and effective for their intended use and are substantially equivalent to the Bose predicate device.

The Concha Sol hearing aids have the same intended use and indications with similar technological characteristics and principles of operation as its predicate device and any differences raise no new questions of safety and effectiveness when compared to the predicate.

Conclusion:

The Concha Sol OTC Hearing Aid has the same intended use and indications for use compared to the predicate device with comparable technological characteristics and principles of operation that do not raise different questions of safety and effectiveness compared to the predicate device. Nonclinical performance testing demonstrated comparable safety and effectiveness with respect to electrical safety, EMC and electroacoustic testing as compared to the primary predicate, Bose SoundControl Hearing Aid (K211008). Similarly, software was developed, tested, and documented in accordance with software development and testing pursuant to IEC 62304:2006+A1:2015, FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" (2005), and demonstrated that the Concha Sol Hearing Aid should perform as intended in the specified use conditions consistent with that reported by the predicate, the Bose SoundControl Hearing Aid.

The usability testing and clinical study provided evidence of clinically meaningful benefit to a population experiencing obstacles to accessibility and affordability of hearing aids. The evidence of clinical effectiveness (verified both quantitatively) validates that the Concha Sol Hearing Aid performs comparably to the clinical effectiveness of the predicate device. The Concha Sol Hearing Aid is substantially equivalent in intended use to the Bose SoundControl Hearing Aid (K211008).

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.