The IQbuds 2 PRO 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 over the counter sale and use without the assistance of a hearing care professional.

Device Description

The Nuheara IQbuds 2 PRO Hearing Aid (Model NU320) is a self-fitting wireless air conduction hearing aid (§ 874.3325) consisting of the hearing aids with Ear Tips. Charge Case, Nuheara software, the Nuheara app, and accessories supplied in the carton. The device is indicated for over-the-counter sale. The hearing aids are designed to be worn in both ears simultaneously with the appropriate size Ear Tips fitted to the sound port of the aid. The device has Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs. In addition to hearing aid functionality for environmental and directive listening (using the microphones on the aids); the hearing aids can be used for making and receiving phone calls and for streaming audio from a Bluetooth®-compliant mobile device that has been paired with the Nuheara Hearing Aids.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the Nuheara IQbuds 2 PRO Hearing Aid meets them, based on the provided document:

The document describes the performance of the Nuheara IQbuds 2 PRO Hearing Aid as part of its 510(k) premarket notification to the FDA, demonstrating its substantial equivalence to predicate devices. The studies primarily focus on usability and clinical performance to show effectiveness and safety.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a clean table format with specific numerical targets for usability or clinical performance in the same way it does for electro-acoustic characteristics. Instead, the acceptance criteria for Usability and Clinical Performance appear to be demonstrated by showing that the device is safe and effective for its intended use by the target population and that its performance is comparable to established benchmarks or predicate devices.

For Electro-Acoustic Characteristics, the acceptance criteria are implicit: the device must meet or be within the established standards (ANSI S3.22 and CTA 2051:2017) and be comparable to the predicate device.

Implicit Acceptance Criteria and Reported Performance (derived from the text):

Feature/Metric	Implicit Acceptance Criteria / Comparison Standard	Reported Device Performance/Study Findings
Usability	Device must be safe and effective for intended users to operate without professional assistance, demonstrating that identified use-related risks are mitigated.	Demonstrated that the device was safe and effective to operate by the intended user when used in accordance with its intended use. Usability was analyzed, verified, and validated; mitigations for user training and device labeling were adequate. No tasks identified as "critical," 3 deemed "essential" (warnings/cautions from User Guide) which implies these were addressed.
Clinical Effectiveness (Overall)	Device provides clinically meaningful benefit for individuals with perceived mild to moderate hearing impairment, comparable to established fitting algorithms (NAL-NL2) and reference devices/literature.	Quantitative Comparison (REIG vs. NAL-NL2): Ear ID™ provides acceptable margins of amplification, within ± 5 dB range, from prescribed targets (NAL-NL2), when averaged across the group. APHAB: Improved mean scores (lower scores) in aided condition for ease of communication in noise (17.8 points), in quiet (7.4 points), and in reverberation (8.2 points). Global improvement of 11 points. Unaided to Aided differences well within published 5-30% percentile norms. Outcomes consistent with studies using NAL-NL2 fit (e.g., Valente et al., 2018; Abrams et al., 2012). SSQ: Results (Speech: 7, Spatial: 7.1, Qualities: 7.2) were comparable to Valente study (Speech: 6.8, Spatial: 7.5, Qualities: 7.9) which used NAL-NL2 fit. Speech in Noise: 86% recall when directionality was employed, improving from 56% unaided or aided without directional microphone.
Electro-Acoustic Characteristics (examples)	Must meet ANSI/ASA S3.22 and CTA 2051:2017 standards, comparable to predicate.	Latency: 5ms (Predicate: ≤ 15 ms). Meets requirements, same as predicate. Frequency response: 200Hz - 8000 Hz (Predicate: 200Hz - 8000 Hz). Same as predicate. Input Distortion: ≤ 5% (measured 0.7%) (Predicate: ≤ 5%). Meets requirements, same as predicate. Equivalent Input Noise (EIN): 28.5 dB SPL (Predicate: 26 dB). Meets requirements, same as predicate. Harmonic Distortion: 0.2% (Predicate: ≤ 5%). Meets requirements, same as predicate. Max OSPL90: 109.6 dB SPL (Predicate: 115 dB SPL, Reference: 120 dB SPL). Meets requirements, same as predicate. HFA OSPL90: 100.9 dB SPL (Predicate: 112 dB SPL, Reference: 111 ± 2 dB SPL). Meets requirements, lower than predicate but does not introduce safety questions. HFA FOG: 29.4 dB SPL (Predicate: 43 dB, Reference: 40 ± 2 dB). Meets requirements, lower than predicate but does not introduce safety questions. RTG: 24.4 dB SPL (Predicate: 36 dB, Reference: 34 ± 4 dB). Meets requirements, lower than predicate but does not introduce safety questions.
Biocompatibility	Must meet ISO 10993 standards and not pose biological risks.	Passed all relevant non-clinical performance testing and biological endpoints: cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO 10993-10:2010).
Electrical Safety, EMC, Battery Safety, Software	Must meet relevant IEC and ISO standards and FDA guidance, mitigating risks to an acceptable level consistent with predicate.	Passed all relevant non-clinical performance testing. Software developed, tested, and documented per IEC 62304:2006+A1:2015, FDA guidances (Software Contained in Medical Devices 2005, Cybersecurity in Medical Devices 2018). Demonstrated mitigation of risks to acceptable level and reasonable assurance of safe and effective non-clinical performance, consistent with predicate.

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

Usability Testing:
- Sample Size: Eighteen (18) adults.
- Data Provenance: The study was conducted in a "quiet, comfortable room" for one-on-one sessions, implying a controlled, prospective study. The location is not explicitly stated (e.g., country of origin), but the context of an FDA submission for a US market suggests it was likely conducted in the US or in compliance with US regulatory standards.
Clinical Performance Study:
- Sample Size: Forty-three (43) adults.
- Data Provenance: This was a "prospective investigation." Similar to usability, the exact country is not stated, but it's part of a US FDA submission.

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

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the test set in the same way one might expect for imaging studies.

Usability Testing: "An independent, trained moderator conducted each session." It doesn't specify if experts established a 'ground truth' for whether a task was performed correctly beyond the scoring of completion by the moderator and review by a "cross-functional team."
Clinical Performance Study:
- NAL-NL2 Reference: The "audiologist determined REM using standard audiologic practice (NAL-NL2)" serves as a direct ground truth. This implies audiologists were involved.
- Subjective Questionnaires (APHAB, SSQ): These are self-reported measures, so the "ground truth" is the participant's own perception, not expert-established.
- Speech in Noise: This involves objective performance (percent recall of sentences) vs. a known noise background.
- The "Ear ID feature... was developed and validated by National Acoustics Laboratories (NAL)." This indicates expert development of the core self-fitting algorithm.

No explicit mention of a "number of experts" for adjudication or ground truth per test case.

4. Adjudication Method for the Test Set

The document does not describe a formal "adjudication method" like 2+1 or 3+1, which is common in radiologic image interpretation studies.

Usability Testing: Participants were "scored on status of completion of all steps in each of the tasks." A "cross-functional team reviewed outcomes at frequent intervals and addressed changes." This implies consensus or review, but not a specific adjudication protocol.
Clinical Performance Study: The methods used (comparison to NAL-NL2, self-reported questionnaires, objective speech-in-noise tests) are direct measurements or comparisons against established audiological standards, not subject to typical human reader adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense of human readers interpreting medical images with and without AI assistance. This device is a self-fitting hearing aid, not an AI for image interpretation.

The clinical performance study does compare the performance of the device's self-fitting method (Ear ID) to established audiological practices (NAL-NL2) and to the unaided condition, demonstrating clinical effectiveness. This serves a similar purpose of demonstrating effectiveness, but via audiological metrics rather than MRMC.

Effect Size (Unaided vs. Aided performance from APHAB):
- Unaided to Aided difference in mean scores (lower is better):
  - Ease of Communication (EC) in quiet: 7.4 points
  - Reverberation (RV): 8.2 points
  - Background Noise (BN): 17.8 points
  - Global Score: 11 points
- These improvements were "well within the published 5-30 (%) percentile norms for the APHAB (Cox and Alexander, 1995)." The study also references Valente et al., 2018, which showed a significant median advantage of 4.2% for NAL-NL2 fitted subjects vs. manufacturer default fit for the background noise subscale problem score.

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

Yes, the "Clinical Performance" study effectively assesses the standalone performance of the device's self-fitting algorithm (Ear ID) by:

Quantitatively comparing target gain from the self-fit (Ear ID) to audiologist-determined NAL-NL2 REM targets. This is a direct measure of the algorithm's output against a gold standard.
The entire premise of a "self-fitting" hearing aid is that the algorithm (Ear ID) performs the fitting function without professional human intervention in the loop.

7. The Type of Ground Truth Used

Clinical Performance:
- Expert Consensus/Standard Practice: For the quantitative comparison, the ground truth was "audiologist determined REM using standard audiologic practice (NAL-NL2)." This represents a professional, expert-established standard.
- User Performance/Subjective Outcomes: For the APHAB and SSQ, the ground truth is the individual participant's self-reported perception of their listening experience and sound quality. For Speech in Noise, it's the objective percentage of recalled sentences.
Usability Testing: The ground truth for task completion was based on the success/failure observed by a trained moderator against predefined task steps.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" for the device's main self-fitting algorithm. The Ear ID system is described as using a "validated NAL-NL2 fitting algorithm" developed by National Acoustics Laboratories (NAL). NAL-NL2 is a widely recognized and established prescriptive formula for hearing aid fitting, not typically something a new device "trains" on in the machine learning sense. Instead, the device implements this algorithm.

If there were any machine learning components (e.g., for noise reduction or sound processing features), the training data for those are not disclosed in this document. The focus here is on the validation of the implementation of the NAL-NL2 principle and the device's overall performance.

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

As noted above, there's no explicitly mentioned "training set" for the core self-fitting algorithm (Ear ID) in the machine learning sense that would require a separate ground truth establishment. The Nuheara IQbuds 2 PRO Hearing Aid utilizes the "validated NAL-NL2 fitting algorithm." The ground truth for NAL-NL2 itself (as a prescriptive target based on audiometric data) is an established audiological standard developed through extensive research and clinical validation by the National Acoustics Laboratories.

Summary

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

Image /page/0/Picture/0 description: The image contains 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 30, 2022

Nuheara Limited % Deborah Arthur Regulatory Consultant DArthurConsulting 4830 Randolph Rd., Unit 3302 Charlotte, North Carolina 28211

Re: K221064

Trade/Device Name: Nuheara IQbuds 2 PRO Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: OUH Dated: March 31, 2022 Received: April 11, 2022

Dear Deborah Arthur:

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.

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

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

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 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,

Srinivas Nandkumar, Ph.D. 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) K221064

Device Name Nuheara IQbuds 2 PRO 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.

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

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."

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

Image /page/4/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized sound wave graphic above the word "NUHEARA" in a bold, sans-serif font. The sound wave graphic is composed of vertical bars of varying heights, with the central bars forming a stylized "N". The logo is in black and white.

510(k) Premarket Notification K221064

510(k) Summary - Nuheara Limited

1. SUBMITTER

Nuheara Limited 13555 S.E. 36th St. Ste. 100 Bellevue, WA 98006 U.S.A.

Contact Person: John Luna

Date Prepared: October 25, 2022

2. DEVICE [PER 807.92(a)(2)]

Name of Device: Nuheara IQbuds™ 2 PRO Hearing Aid - K221064 Classification Name: Self-fitting Air Conduction Hearing Aid Common Name: Self-fitting Hearing Aid Regulation: 21 CFR §874.3325 Requlatory Class: II Product Code: QUH

3. PREDICATE DEVICE [PER 807.92(a)(3)]

Predicate: Bose Hearing Aid - DEN180026 Reference: BHA100 Series Braun® Clear™ Hearing Aid - K212609

4. DEVICE DESCRIPTION [PER 807.92(a)(4)]

The hearing aids are designed to be worn in both ears simultaneously with the appropriate size Ear Tips fitted to the sound port of the aid. The device has Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs. In addition to hearing aid functionality for environmental and directive listening (using the microphones on the aids); the hearing aids can be used for making and receiving phone calls and for streaming audio from a Bluetooth®-compliant mobile device that has been paired with the Nuheara Hearing Aids.

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

Image /page/5/Picture/0 description: The image is a logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" formed by three vertical bars of varying heights. The logo is simple and modern, and the black and white color scheme gives it a clean and professional look.

510(k) Premarket Notification K221064

The hearing aids are powered using 3.7V Li-lon coin cell batteries and the Charge Case powered using a Li-Ion Polymer battery. They can be recharged 'on the go' using the Charge Case, which can fully recharge the hearing aid battery three times before the Charge Case requires recharging. The Charge Case also serves as a helpful carrying case to enable mobile charging and protect the hearing aids while not in use.

5. Intended Use

The Nuheara IQbuds 2 PRO self-fitting wireless air conduction hearing aids are intended to amplify sound for individuals with perceived mild to moderate hearing impairment.

6. Indications for Use

The Nuheara IQbuds 2 PRO self-fitting hearing aids are intended to amplify sound for individuals 18 years and 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 over the-counter sale and use without the assistance of a hearing care professional.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

The intended use and technological characteristics, e.g., features, parameter settings etc. are substantially equivalent to the predicate device (Bose) cited above. Table 1 summarizes the characteristics of the Nuheara IQbuds 2 PRO Hearing Aids in comparison to the predicate, the Bose Hearing Aid (DEN180026) and, as applicable, the reference device (BHA100 Series Braun® Clear™ Hearing Aid - K212609). The BHA100 device serves a reference device as the self-fitting strategy (i.e., self-administered hearing test and subsequently applied prescription) is similar to the subject device.

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

Image /page/6/Picture/0 description: The image is a logo for Nuheara. The logo consists of the word "NUHEARA" in all caps, with a stylized "N" above it. The "N" is made up of three vertical bars of varying widths, with the middle bar being the thickest.

510(k) Premarket Notification
K221064

Table 1. Summary of Technological Characteristics

	Subject	Predicate	Reference
Device Tradename	Nuheara IQbuds™ 2 PRO	Bose Hearing Aid	BHA100 Series Braun®Clear™ Hearing Aid	Discussion of Differences
510k Number	K221064	DEN180026	K212609
Product code	QUH	QDD	QDD	The over-the-counter version of theself-fitting hearing aid has an updatedproduct code to differentiate it from theDTC version (QDD). The onlydifference is the updated labeling asrequired by the enactment of the OTCHearing Aid Final Rule on October 17.2022.
Regulationnumber	21 CFR 874.3325	21 CFR 874.3325	21 CFR 874.3325	Same as predicates
Regulation name	Self-fitting air conduction hearingaid	Self-fitting air conductionhearing aid	Self-fitting air conductionhearing aid	Same as predicates
Intended Use	The IQbuds 2 PRO Hearing Aids isintended to amplify sound forindividuals with perceived mild tomoderate hearing impairment.	The Bose Hearing Aid isintended to amplify soundfor individuals withperceived mild tomoderate hearingimpairment.	The BHA100 Series Braun®Clear™ Hearing Aid isintended to amplify sound forindividuals with perceivedmild to moderate hearingimpairment.	Same as predicates
	Indications for Use
Indications for Use	The IQbuds 2 PRO Hearing Aidsare intended to amplify soundfor individuals 18 years of ageor older with perceived mild tomoderate hearing impairment.They are adjusted by the user tomeet the user's hearing needs.No pre-programming or hearingtest is necessary. The device isintended for over-the-countersale and use without theassistance of a hearing careprofessional.	The Bose Hearing Aids areintended to amplify soundfor individuals 18 years ofage or older with perceivedmild to moderate hearingimpairment. They areadjusted by the user to meetthe user's hearing needs.No pre- programming orhearing test is necessary.The device is intended fordirect-to-consumer sale anduse without the assistanceof a hearing careprofessional.	The BHAI00 SeriesBraun® Clear™ HearingAid is a self-fitting, airconduction hearing aid,intended to amplifysound for individuals 18years of age or older withperceived mild tomoderate hearingimpairment. It is adjustedby the user to meet theuser's hearing needs.The device is intendedfor direct-to-consumersale and use without theassistance of a hearinghealth care professional.	Same as predicate and reference
Technology	Rechargeable batteriesLithium-ion polymer	Rechargeable batteryLithium- ion polymer		Subject device battery isrecharged in a 'Charge Case' thatstores and charges the battery atthe same time. While the predicaterecharges by use of an AC plugadapter and connector into hearingaid neckband to recharge. Neitherhearing aid can be used whilecharging.The difference in rechargingprocess does not introduce newissues of safety as both devicesmeet same battery standards
	Subject	Predicate
Device Tradename	Nuheara IQbuds™ 2 PRO	Bose Hearing Aid	BHA100 Series Braun®Clear™ Hearing Aid	Discussion of Differences
Housing	In-the-ear hearing aidhousing. Separate left andright ear units (earbuds) witha separate Ear Tip for eachunit.On device, 'Tap Touch'control to streaming audioand use with phone (viaBluetooth)	Hearing aid neckband housingthat connects to both the left andright ear units with user controlson right earbud wire.Image: Bose Hearing Aid		Although the subjectdevice hearing aidhousing is wireless andin- the ear instead of aneckband with wiredearbuds, the difference inhousing does notraise different questions ofsafety or effectiveness.
Input signalcompression	Wide dynamic rangecompression	Wide dynamic rangecompression		Same as predicate
Microphones	Microphones in the earbud,can be configured by the userduring use; via the Nuhearaapp. To configure themicrophones to switchbetween omni-directional anddirectional sound, in theNuheara app you can togglethe FOCUS feature ON / OFF.	Microphones in earbud may,during use, be configured by theuser in omni-directional ordirectional modes		The subject device, aswell as the predicate,allow for omni-directionaland speech focusoptions.
Battery Life	Per CTA 2051 (4.1-4.17)Battery life of up to 8 hrs	Per CTA 2051 (4.1-4.7)Battery life of 10 hrs	Subject device has a'portable' Charge Case forcharging the hearing aids aany time or place shouldthere be a need for extendeduse.
			The battery life is similar tothat of the predicate.However, the subject deviceoffers the advantage of 'onthe go' charging.The battery life or the 'on thego' charging does not raiseany new issues of safety andeffectiveness.
Noise Reduction	Hybrid Active NoiseCancellation	Active Noise Reduction (ANR)	The subject deviceperforms in a similarmanner to predicate anddoes not raise differentissues of
	Subject	Predicate	Reference
Device Tradename	Nuheara IQbuds™ 2 PRO	Bose Hearing Aid	BHA100 Series Braun®Clear™ Hearing Aid	Discussion of Differences
				effectiveness
Self-fitting method	Subject device uses aproprietary Ear ID, avalidated NAL-NL2 fittingalgorithm,	Loudness and Fine-tuningapp-based Controllers.Utilizes a proprietary fittingalgorithm.	Braun ClearCheckHearing Test is a featureof the BHA100 BraunClear hearing aid. Thisfeature validated usingperformance standardtesting, detects auditorythresholds and partneredwith a smartphone app,delivers user-customizedauditory signal/soundthrough the hearing aid.	The Ear ID feature in the subjectdevice yields hearing assessmentwhich then calculates and appliesNAL-NL2 target gains to self-fittinghearing aid using the app in usersmartphone.Human factors assessment validatesthat the user can effectively utilizethe proprietary Ear ID feature toprofile their hearing needs and thus'calibrate' the device to their uniquehearing profile.In measures of clinical effectiveness,the subject device performance inquantitative and qualitative measuresis consistent with the reference deviceand does not raise different issuesregarding safety and effectiveness
Mobile App	Mobile application on a smartdevice (phone or tablet) witheither iOS or Androidplatforms.	Mobile application on a smartdevice (phone or tablet) witheither iOS or Android platforms.		The subject and predicate deviceutilize a mobile app user interface on asmart device in a similar manner anddo not raise different issues regardingeffectiveness.
Remote firmwareupdates	The subject device via theNuheara app allows forremote firmware updates tothe hearing aids.	The predicate does allow forremote firmware updates.	Allowing for remote firmware updatesare assessed as part of thecybersecurity risk process and riskmitigations are developed per thedevice hazard analysis. This does notraise different questions of safety andeffectiveness.

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

NUHEARA

IQbuds 2 PRO Hearing Aid

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

Image /page/8/Picture/0 description: The image contains the logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" formed by vertical bars of varying heights, resembling a sound wave or equalizer graphic. The logo is simple and modern, using a monochrome color scheme.

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

Image /page/9/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N with vertical bars on either side, resembling a sound wave. Below the symbol is the word "NUHEARA" in a bold, sans-serif font.

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

Image /page/10/Picture/0 description: The image shows the logo for Nuheara. The logo consists of the word "NUHEARA" in a bold, sans-serif font. Above the word is a stylized "N" formed by three vertical bars of varying heights, resembling sound waves. The logo is simple and modern, with a focus on the company name and a visual representation of sound.

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

Image /page/11/Picture/0 description: The image shows the logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" symbol, which is made up of vertical bars of varying heights. The logo is simple and modern, and the black and white color scheme gives it a clean and professional look.

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

Image /page/12/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N, with vertical bars on either side, resembling a sound wave. Below the symbol is the word "NUHEARA" in a bold, sans-serif font.

Electro-Acoustic Characteristics per ANSI S3.22 and CTA 2051:2017
Electro-AcousticCharacteristics	Subject Device	Predicate	ReferenceBHA100 Series Braun Clear	Discussion of Differences
LatencyClause 4.8	5ms	Less than or equal to 15 ms		The subject device meets therequirements, same as predicate.
Frequency response	200Hz - 8000 Hz	200Hz - 8000 Hz		The subject device has the samefrequency response as thepredicate.
Input DistortionClause 4.4.2	Less than or equal to 5%(measure is 0.7%)	Less than or equal to 5%	Non-applicable	The subject device meets therequirements, same as predicate.
Equivalent InputNoise (EIN)Clause:6.12	28.5 dB SPL	26 dB		The subject device meets therequirements, same as predicate.
Harmonic DistortionClause 6.11	0.2%	Less than or equal to 5%		The subject device meets therequirements, same as predicate.
Max OSPL90Clause 6.2	109.6 dB SPL	115 dB SPL	120 dB SPL	The subject device meets therequirements, same as predicate.
HFA OSPL90Clause 6.3	100.9 dB SPL	112 dB SPL	111 ± 2 dB SPL	The subject device meets therequirements and is lower than thepredicate device, which does notintroduce any questions of safety.
HFA FOGClause 6.5	29.4 dB SPL	43 dB	$40\pm2$ dB	The subject device meets therequirements and is lower than thepredicate device, which does notintroduce any questions of safety.
RTGClause 6.7	24.4 dB SPL	36 dB	$34 \pm 4$ dB	The subject device meets therequirements and is lower than thepredicate device, which does notintroduce any questions of safety.

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

Image /page/13/Picture/0 description: The image shows the logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" formed by three vertical bars of varying heights. The logo is in black and white.

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

Image /page/14/Picture/0 description: The image shows the logo for Nuheara. The logo consists of two parts: a stylized symbol and the company name. The symbol is above the name and features a bold "N" with vertical bars on either side, resembling sound waves. The company name "NUHEARA" is written in a bold, sans-serif font below the symbol.

510(k) Premarket Notification K221064

8. Non-Clinical Performance Data

Both the subject and predicate devices were tested for conformity to the following FDA recognized consensus standards applicable to the self-fitting hearing aid for its intended use.

Biocompatibility

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

Electro-Acoustics

ANSI/ASA S3.22 2014 Measurements ●
CTA 2051: 2017 ●

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

Image /page/15/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter "N" with sound wave-like bars on either side, positioned above the word "NUHEARA" in a bold, sans-serif font. The entire logo is in black against a white background.

510(k) Premarket Notification K221064

In order to establish substantial equivalence to the predicate device, Nuheara evaluated the electroacoustic data as found in the predicate and required under Special Controls for 21 CRF §874.3325. As seen in the Electro-Acoustic Characteristics per ANSI S3.22 and CTA 2051:2017 table above, the measurement for the specific cited clauses indicates that the Nuheara IQbuds 2 PRO Hearing Aids are substantially equivalent in acoustic performance to the predicate, Bose Hearing Aid (DEN180026).

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

Image /page/16/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized "N" formed by vertical bars of varying heights, resembling a sound wave. Below the symbol is the word "NUHEARA" in a bold, sans-serif font.

Electrical Safety, EMC, Battery Safety, Software and Labeling

IEC 60601-1; 2005 + AMDI:2012.
IEC 60601-1-2; 2014, AMDI:2020;Part 1-2:
IEC 60601-2-66:20191
· IEC 62133-2, Edition 1.0: 2017-02
· ISO 15223-1:2016 Medical devices
· IEC62304: 2006; 1st Edition +A1:2016; Software life cycle processes

Consistent with the predicate device, the Nuheara IQbuds 2 PRO Hearing Aids passed all relevant non-clinical performance testing and biological endpoints, namely cytotoxicity (ISO 10993-05:2009) sensitization, and intracutaneous reactivity (ISO 10993-10:2010).

Similarly, software verification and validation, testing to established consensus standards for electrical safety, EMC and battery safety demonstrated mitigation of risks to an acceptable level as well as reasonable assurance of safe and effective device non-clinical performance, consistent with the predicate, the Bose Hearing Aid.

9. USABILITY TESTING AND CLINICAL PERFORMANCE DATA

Usability Testing

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

Eighteen adults (18 yrs. and older) with a perceived mild to moderate hearing loss hearing loss were enrolled after passing screening of inclusion/exclusion criteria. Task driven Formative Evaluations followed by an inclusive Evaluation were conducted in a one-on-one quiet, comfortable room fit with two chairs and a table on which the participants could handle the device and a smartphone. Informed Consent was obtained for each participant before enrollment and all sessions were video-taped.

While no tasks were identified that met the criteria for 'critical' there were 3 deemed 'essential' (device is not hearing protection and other warnings/cautions from the User Guide). An independent, trained moderator conducted each session which involved a series of steps for accessing, fitting and then using the hearing aid in simulated use conditions. All participants were scored on status of completion of all steps in each of the tasks. A cross-functional team reviewed outcomes at frequent intervals and addressed changes to be considered to labeling, product packaging, and iterative minor

1 Not FDA recognized but applicable to the device and its intended use; also included to be consistent with predicate, Bose Hearing Aid.

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

Image /page/17/Picture/1 description: The image shows the logo for Nuheara. The logo consists of a stylized "N" formed by vertical bars of varying heights, resembling sound waves. Below the symbol is the word "NUHEARA" in bold, sans-serif capital letters.

510(k) Premarket Notification K221064

design changes to the user interface to accommodate the user needs. The same crossfunctional team reviewed and approved the Summative Evaluation Report. The evaluation provided evidence that the device was safe and effective to operate by the intended user when used in accordance with its intended use.

Overall, the human factors study demonstrated that the usability of the Nuheara hearing aid was analyzed, verified, and validated for its intended use, intended use environment and the implemented mitigations for user training and device labeling are adequate.

Clinical Performance

Clinical Performance with the Nuheara IQbuds 2 PRO Hearing Aid was assessed with a prospective investigation of the clinical effectiveness with the Nuheara IQbuds 2 PRO self-fitting hearing using standard audiological assessment metrics in 43 adults, mean age of 50 and self-identified with a perceived mild to moderate hearing loss. They were evaluated using well established clinical measures and real-world scenarios. This validation of the Nuheara self-fitting methodology for the target population (adults with perceived mild to moderate hearing loss) used an assessment approach similar to that of the reference BHA100 Series Braun Clear Hearing Aid by assessing clinical effectiveness quantitatively and qualitatively. Those measures involved the following:

Quantitatively comparing target gain from the audiologist determined REM using . standard audiologic practice (NAL-NL2) against the participant completed self-fit using the Nuheara Ear ID feature.
Image /page/17/Figure/8 description: The image contains three line graphs showing REIG rel-Targets (dB) on the y-axis and Frequency (Hz) on the x-axis. The graphs represent different sound pressure levels: 55dB SPL, 65dB SPL, and 80dB SPL. Each graph displays a black line with blue dashed lines above and below, along with two horizontal orange lines. Additionally, the 80dB SPL graph has two vertical dotted lines at approximately 3500 Hz and 5950 Hz.

This figure shows the REIG calculated deviations measures and corresponding 95% confidence intervals, based on the t-score method. The figure shows that REIG lies with ± 5 dB from NAL-NL2 target for frequencies below 3.5 kHz.

Assessing perceptual measures of device effectiveness by utilizing the well . characterized and validated APHAB and SSQ-12 self-reported questionnaires and EMA for real-time self-reporting of user listening experience while aided

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

Image /page/18/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized "N" formed by three vertical bars of varying heights, with the middle bar forming the letter "N". Below the symbol is the word "NUHEARA" in a bold, sans-serif font. The logo is simple and modern, and the use of the "N" symbol makes it easily recognizable.

510(k) Premarket Notification K221064

(shown below).

A Real Ear Insertion Gains measure (REIG) allowed for amplification levels calculated and applied by Ear ID™ to be compared to the targeted NAL-NL2 prescription. The results indicate that when averaged across the group, the Ear ID™ provides acceptable margins of amplification, within ± 5 dB range, from prescribed targets.

APHAB

The Ear ID feature of the IQbuds 2 PRO was developed and validated by National Acoustics Laboratories (NAL) to the widely recognized hearing aid fitting algorithm, NAL-NL2. This fitting strategy has been incorporated and validated in multiple clinical studies as the primary 'comparator' representing a best fit (e.g., Valente et al., 2018). In the IQbuds 2 PRO clinical performance assessment, the APHAB was used to compare participant subjective outcomes in the unaided and aided conditions.

Clinical effectiveness of the IQbuds 2 PRO Self-Fit hearing aid is evidenced in the analysis of the four subscales of the APHAB questionnaire (Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV) of sound). The results of the 43 subjects in a global score are shown on the table below. The global scores are calculated as the average of the EC, BN, and RV subscale scores.

UNAIDED					AIDED
	EC	BN	RV	AV	GlobalScore	EC	BN	RV	AV	GlobalScore
Mean	22.4	45.1	31.8	41.9	33.1	14.3	28.3	23.6	41.2	22.1
SD	19.1	19.1	18.7	23.9	16.9	16.3	17.8	17.4	26.8	15.3
N	43	43	43	43	43	43	43	43	43	43

This table shows the mean scores for the 43 subjects from the study of clinical performance in each of the APAB subscales and then the overall Global Score. Benefit is derived by comparing unaided to aided values.

Results indicated the Nuheara Self-Fit aided condition improved the mean scores (i.e., lower scores) for ease of communication in noise by 17.8 points; in quiet by 7.4 points; and in reverberation - 8.2 points, out of a total score of 100. The global improvement was 11 points better when aided with the IQbuds 2 PRO Self-Fit. The Unaided to Aided difference in the scores were well within the published 5-30 (%) percentile norms for the APHAB (Cox and Alexander, 1995).

As the IQbuds 2 PRO Self-Fit is based on NAL-NL2, it is appropriate to look at other studies of hearing aids programmed to meet that industry standard formula with REM confirmation and incorporating the APHAB as a measure of clinical effectiveness. The most significant to date would be Valente M. et al., 2018, which had a similar study

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

Image /page/19/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N with vertical lines on either side, resembling sound waves. Below the symbol is the word "NUHEARA" in a bold, sans-serif font. The logo is in black and white.

population across multiple criteria and also incorporated a 4-week aided, home trial. Their study showed a significant advantage for the NAL-NL2 fitted subjects (compared to manufacturer default fit) with a significant median advantage of 4.2% (p < 0.04; 95% confidence interval (CI): 20.6-13.2%) for the programmed-fit (NAL-NL2) compared with the first-fit for the background noise subscale problem score for the APHAB. These outcomes incorporating NAL-NL2 fit-programs as a comparator are also consistent with the findings of Abrams, Chisolm, McManus, & McArdle (2012) in a similar study.

ടടവ

This validated assessment scale groups 'sound' into three main categories – speech, spatial and quality. The intent is to determine the individual's perceived level of disability in different listening environments. When outcomes between the IQbuds 2 PRO participants were compared to those in the Valente study using the NAL-NL2 fit, the results were comparable for all three categories:

SSQ	Valente	Nuheara
Speech	6.8	7
Spatial	7.5	7.1
Qualities	7.9	7.2

Speech in Noise

A modification of the BKB-like sentences (Bench et al., 1979) was adapted by NAL to Australian English. The sound field configuration introduced multi-talker babble noise presented from three loudspeaker locations at 120-, 180- and 240-degrees locations. On average, participants scored 56% recall when unaided or aided without directional microphone but with performance increasing to 86% when directionality was employed.

10. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Nuheara IQbuds 2 PRO™ 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. The Nuheara IQbuds 2 PRO™ Hearing Aid uses a similar self-fitting strategy as the reference device. Also similar to the reference device, the subject device leverages subjective measures to demonstrate clinical benefit.

Non-clinical performance testing demonstrated equivalent safety and effectiveness with respect to electrical safety, EMC, radio/telecommunications, and electroacoustic testing as compared to the predicate, the Bose Hearing Aid (DEN180026). 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 with "Content of premarket Submissions for Management of Cybersecurity in Medical Devices"

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

Image /page/20/Picture/1 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N with vertical lines on either side, resembling sound waves. Below the symbol is the company name, "NUHEARA," in bold, sans-serif capital letters.

(2018) and demonstrated that the IQbuds 2 PRO Hearing Aid should perform as intended in the specified use conditions consistent with that reported by the predicate, the Bose Hearing Aid.

The usability testing and clinical study provided validation that risks to health have been mitigated to an acceptable level as well as reasonable assurance of safety and effectiveness and evidence of clinically meaningful benefit to a population experiencing obstacles to accessibility and affordability of hearing aids. The IQbuds 2 PRO Hearing Aid is substantially equivalent in intended use to the predicate device, the Bose Hearing Aid (DEN180026) and similar to the self-fitting strategy in the reference device, the BHA100 Series Braun® Clear™ Hearing Aid. The clinical performance data for the IQbuds 2 PRO Hearing Aids shows reasonably similar outcomes to that in literature that used NAL-NL2 in a professional fit condition.

Overall, based on the results of non-clinical, usability and clinical performance testing, risks to health have been mitigated to an acceptable level and the benefits of the IQbuds 2 PRO clearly outweigh the potential risks to health providing evidence that IQbuds 2 PRO is substantially equivalent to the Bose Hearing Aid when used as intended and in accordance with its Instructions for Use.

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.