The Jabra Enhance Plus self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

Device Description

The Jabra Enhance Plus is a wireless, self-fitting air-conduction hearing aid system. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth Low Energy using the mobile app, the Jabra Enhance, installed on a compatible iPhone, iOS 14 or later. Further control of the earbuds is possible via an on-device user control button on both the Left and Right earbud. In addition to hearing aid functionality for environmental listening, the Jabra Enhance Plus earbuds can be used for placing and receiving telephone calls and for streaming audio from a compatible, Bluetooth compliant mobile device that has been paired with the earbuds. The controls accessible through the Jabra Enhance mobile app and on the earbuds are used to configure parameters, settings, and listening modes of the earbuds. The earbuds integrate a rechargeable 3.7V/15mAh li-ion battery coin cell inside each earbud, and they are recharged by the on-the-go charging case that also serves as a carrying case. The mobile app is connected to the Internet Services that enable remote upgrades to the earbud firmware in support of continued enhancements.

AI/ML Overview

The provided document is a 510(k) Summary for the Jabra Enhance Plus self-fitting air-conduction hearing aid. It outlines the device's characteristics, comparison to a predicate device (Bose Hearing Aid), and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state acceptance criteria in numerical targets for all aspects, but rather compares the Jabra Enhance Plus (Subject Device) to a predicate device (Bose Hearing Aid) and relevant standards. The "Discussion" column often acts as a statement of meeting implied criteria (e.g., "Same as predicate," "Comparable to predicate and suitable for the intended user"). Performance is reported against technical standards and clinical equivalence.

Evaluation Criterion / Characteristic	Acceptance Criteria (Implied/Standard)	Reported Device Performance (Jabra Enhance Plus)	Discussion (Meeting Acceptance)
Indications for Use	Same as predicate (amplify sound for individuals 18+ with perceived mild to moderate hearing impairment, self-adjusted, no pre-programming/hearing test, direct-to-consumer, no professional assistance)	Same as predicate	Met: "The Indications for Use are the same."
Intended Use	Same as predicate (amplify sound for individuals 18+ with perceived mild to moderate hearing impairment)	Same as predicate	Met: "The intended uses are the same."
Technological Characteristics
Housing	Biocompatibility and safety characteristics comparable to predicate.	In-ear earbuds (different from predicate's neckband)	Met: "difference in housing does not raise different questions of safety or effectiveness. Biological safety characteristics same as predicate device. Nonclinical data from biological safety testing and data from a clinical validation study support substantial equivalence."
Wireless communication	Wireless communication with handheld device via Bluetooth	Wireless communication with handheld device via Bluetooth	Met: "Same as predicate"
Wireless coexistence	Complies with AAMI TIR 69 (temporary loss of Bluetooth communication a negligible risk)	Uses 2.4GHz Classic Bluetooth and BLE; risk assessment determined temporary loss of Bluetooth communication from interfering RF signals is negligible.	Met: "Same as predicate"
Wireless user control functions via mobile app	Functionally similar to predicate. Fine-tuning options typical for mild-moderate hearing loss.	Volume Control (-12dB to +6dB), Listen Mode (Surround, adaptive, focus), Preferred filter (full, normal, clear)	Met: "Bose Hearing Aid allows for Left/Right balance control, however Left/Right balance is achieved through the self-fitting process in the subject device and as such, is inherent in the self-fitted device. The additional Bose Left/Right balance does not raise different questions of safety or effectiveness. Nonclinical data from a formative usability study and data a clinical validation study support substantial equivalence."
Bluetooth pairing, control, streaming	Verification with paired mobile device	Pairing, control, streaming verification with the paired mobile device.	Met: "Same as predicate"
Battery life	Rechargeable, providing ~10 hours of battery life	Rechargeable 3.7V/15mAh li-ion battery coin cells, 10 hours battery life (implied from discussion)	Met: "While battery capacity is different, both devices are rechargeable and allow for 10 hours of battery life on a full charge, and as such the difference in battery capacity does not raise different questions of safety or effectiveness."
Charging	Safe charging method not raising new questions of safety/effectiveness	Proprietary On-The-Go charging case via physical connection (Pogo pins), with internal 3.7V/129mAh li-ion battery for on-the-go charging, supports USB power.	Met: "Charging the subject device hearing aids in a portable charging case with or without connecting the charging case to a power supply via a USB cable does not raise different questions of safety or effectiveness. Non-clinical data from a formative usability study support substantial equivalence."
Microphones	Omnidirectional and directional modes, suitable for intended use.	Omnidirectional or directional modes (Surround, adaptive, focus). Supports adaptive directional mode.	Met: "The added automatic selection of directionality does not raise different questions of safety or effectiveness... Clinical data from peer-reviewed literature (Wu et al. Ear Hear. 2019) and a clinical validation study support substantial equivalence."
Device control	Comparable to predicate, not raising new safety/effectiveness questions.	On-Device user controls for volume, mute, mobile calls. Bluetooth pairing via removal from charging case.	Met: "The added call controls and different means of engaging BlueTooth pairing do not raise new questions for safety or effectiveness. Nonclinical data from a summative usability study and data from a clinical validation study support substantial equivalence."
Compression	Channels allowing for similar spectral tilt as predicate.	17 channel wide band dynamic range compression	Met: "The 5 additional channels... offer similar spectral tilt as predicate device. The 5 additional channels do not raise different questions of safety or effectiveness. Data from a clinical validation study support substantial equivalence."
Noise reduction	Proven effective, not raising new safety/effectiveness questions.	Steady-state noise reduction, impact noise control. No active noise reduction. (Different from predicate).	Met: "While differences in the implementation of noise cancellation exist, the methods developed by GN Hearing have proven effective in products already on the market, and therefore do not raise different questions of safety or effectiveness. Clinical data from peer-reviewed literature (Wu et al. Ear Hear. 2019) and a clinical validation study support substantial equivalence."
Feedback cancellation	Feedback canceller present	Feedback canceller	Met: "Same as Predicate"
Telephone calls	Placing and receiving telephone calls capability	Placing and receiving telephone calls	Met: "Same as Predicate"
Mobile App compatibility	Not raising different safety/effectiveness questions even with reduced compatibility.	iOS only (Predicate compatible with iOS & Android).	Met: "The lack of compatibility with handheld Android devices does not raise different questions of safety or effectiveness. Nonclinical data from a summative usability study and data from a clinical validation study support substantial equivalence."
Self-fitting method	Validated algorithm, not raising different safety/effectiveness questions.	NAL-NL2 fitting algorithm	Met: "NAL-NL2 is widely used by hearing care professionals... As such the difference in fitting does not raise different questions of safety or effectiveness. Data from a clinical validation study support substantial equivalence."
Remote Firmware update	Cybersecurity risks assessed and mitigated, not raising different safety/effectiveness questions.	Allows remote firmware update via app/cloud.	Met: "This feature does not raise different questions of safety or effectiveness. Nonclinical data documented in the cyber risk register support substantial equivalence."
Exposure to nonionizing radiation (IEC 62479:2010)	Sufficiently safe in terms of human exposure to nonionizing radiation.	Passes according to IEC 62479:2010.	Met: "Comparable to predicate. Uses same Bluetooth technology. Nonclinical data from verification testing in accordance with IEC 62478:2010 (human exposure to electromagnetic fields) support substantial equivalence."
Electroacoustic characteristics (ANSI/ASA S3.22-2014 & ANSI/CTA 2051:2017)	Comparable to predicate and suitable for intended user. Latency <15ms, THD <5%.	Frequency range: 100-8700 Hz. Max output: 110 dB SPL. Eq. noise input: 26dB. HFA FOG: 25 dB. Latency: <15ms (5.6 ms). THD@500Hz: 0.4%, @800Hz: 0.4%, @1600Hz: 1.0%, @3200Hz: 0.3%.	Met: "Comparable to predicate and suitable for the intended user... Latency and total harmonic distortion meet the requirements in ANSI/CTA 2051-2017... do not raise different questions for safety or effectiveness."
Maximum Acoustic Output Sound Pressure Level Input 90dB SPL (Max OSPL90)	<= 120 dB SPL	110 dB SPL	Met: "Same as predicate"
Harmonic Distortion (Output Distortion)	<= 5%	500 Hz 0.4%, 800 Hz 0.4%, 1600 Hz 1.0%, 3200 Hz 0.3% (all < 5%)	Met: "Same as predicate"
Equivalent Input Noise (EIN)	<= 32 dB SPL	24 dB SPL	Met: "Same as predicate"
High Frequency Average Output Sound Pressure Level (HFA OSPL 90)	Adequate for fitting mild to moderate hearing loss as prescribed by NAL-NL2.	104 dB SPL (Predicate: 112 dB SPL)	Met: "Adequate for fitting mild to moderate hearing loss as prescribed by NAL-NL2. Data from a clinical validation study support substantial equivalence."
High Frequency Average Full On Gain (HFA FOG)	Adequate for fitting mild to moderate hearing loss as prescribed by NAL-NL2.	26 dB (Predicate: 43 dB)	Met: "Adequate for fitting mild to moderate hearing loss as prescribed by NAL-NL2. Data from a clinical validation study support substantial equivalence."
Reference Test Gain (RTG)	Adequate for fitting mild to moderate hearing loss as prescribed by NAL-NL2.	25 dB (Predicate: 36 dB)	Met: "Adequate for fitting mild to moderate hearing loss as prescribed by NAL-NL2. Data from a clinical validation study supports substantial equivalence."
Safety (Adverse Events)	No AEs or SAEs	No AEs or SAEs recorded	Met: "The safety endpoint of the clinical validation study was met. There were no recorded Adverse Events (AEs) or Serious Adverse Events (SAEs) at either study site during the study."
Reliability of Self-fitting	Statistically equivalent REAR and QuickSIN results for repeated self-fit procedure.	Statistically equivalent REAR (500, 1000, 4000 Hz) and QuickSIN scores for SELF-FIT A and B.	Met: "Repetition of the self-fitting procedure resulted in statistically equivalent REAR and QuickSIN results. These findings... provide evidence that the self-fitting procedure for the Jabra Enhance Plus hearing aid is very reliable."
Non-inferiority to professional fitting (APHAB-global score)	SELF-FIT statistically non-inferior to PRO-FIT.	SELF-FIT was statistically non-inferior to PRO-FIT, and scores were nearly identical to predicate.	Met: "Analysis of the APHAB-global score revealed that SELF-FIT was statistically non-inferior to PRO-FIT."
Non-inferiority to professional fitting (QuickSIN scores)	Performance with SELF-FIT statistically non-inferior to PRO-FIT.	Performance with SELF-FIT was statistically non-inferior to PRO-FIT.	Met: "Performance with SELF-FIT was statistically non-inferior to that with PRO-FIT."

2. Sample Size for the Test Set and Data Provenance

Clinical Validation Study (Test Set):
- Sample Size: 38 subjects (19 at each clinical site) for the initial in-lab session. 37 subjects for the wear-time field trial.
- Data Provenance: Two geographically disparate U.S. clinical audiology sites. The study was prospective.
Usability Testing (Summative Usability Study):
- Sample Size:
  - 21 participants who were not intended device users (for external packaging and labeling).
  - 15 intended users (i.e., those with mild-moderate hearing loss) for functional usability (setting up earbuds).
- Data Provenance: Not explicitly stated, but implies U.S.-based given the FDA submission context. Prospective.

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

Clinical Validation Study (for PRO-FIT comparison): Ground truth for the "PRO-FIT" (professional fitting) condition was established by an audiologist at each clinical site. The description refers to "an audiologist fit the same device using in situ NAL-NL2 real ear aided response (REAR) targets." This implies at least two audiologists (one per site). Their specific qualifications (e.g., years of experience) are not detailed.
Self-fitting method: The "ground truth" for the self-fitting aspect of the device is based on the NAL-NL2 prescription algorithm, which is a validated and widely used algorithm in audiology.

4. Adjudication Method for the Test Set

Clinical Validation Study: The clinical study was a cross-over, within-subject (repeated measures) wear-time field trial. Subjects were blinded as to which fitting (SELF-FIT or PRO-FIT) they were wearing during the field trial. This blinding serves as a form of "adjudication" against bias in subjective reporting. For objective measures like REAR and QuickSIN scores, statistical analysis was used to compare the conditions. No explicit "expert panel" style adjudication is mentioned.

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

No, this was not an MRMC study in the traditional sense. MRMC studies are typically for diagnostic imaging where multiple readers interpret cases.
This was a clinical validation study comparing two fitting methods (self-fit vs. professional-fit) of the same hearing aid device in human subjects. The study assessed the effectiveness of one method (self-fitting) compared to another (professional fitting) and showed non-inferiority for the self-fitting method, not an improvement of human readers with AI assistance.
Effect Size: The study reported that the SELF-FIT was statistically non-inferior to PRO-FIT for APHAB-global scores and QuickSIN scores. For APHAB-global scores, the mean scores for SELF-FIT and PRO-FIT were "nearly identical," indicating very similar performance. For REAR, while SELF-FIT showed slightly less high-frequency gain than PRO-FIT, it was determined to be "ultimately inconsequential to performance" as evidenced by functional outcomes. The equivalence region for QuickSIN was ±1.5 dB, and equivalence was found within this range.

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

Yes, in essence, the "SELF-FIT" condition represents a standalone algorithm performance (without professional human intervention). The device self-fits based on user input and the NAL-NL2 algorithm. The clinical study's primary goal was to validate the reliability and effectiveness of this standalone self-fitting method by comparing it to a professionally-fitted version of the same device. The entire field trial evaluated the device being used "without the assistance of a hearing care professional."

7. The Type of Ground Truth Used

Clinical Validation Study:
- Expert Consensus/Standard: For the "PRO-FIT" condition, the ground truth was based on a best-practices professional fitting using in situ NAL-NL2 real ear aided response (REAR) targets by an audiologist.
- Clinical Outcomes Data: For effectiveness endpoints, QuickSIN scores (speech-in-noise test) and APHAB questionnaires (patient-reported outcome of hearing aid benefit) were compared. These are standardized and validated clinical outcome measures reflecting functional performance and patient perception.
- Objective Measures: REAR measurements were used to objectively assess the acoustic output of the hearing aid in the ear.
Biocompatibility: In-vitro and in-vivo testing according to ISO 10993 standards (e.g., cytotoxicity, sensitization, intracutaneous reactivity).
Electroacoustic Performance: Ground truth derived from established industry standards like ANSI/ASA S3.22-2014 and ANSI/CTA 2051:2017.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set used to develop or train the Jabra Enhance Plus's self-fitting algorithm. The "self-fitting method" utilizes the validated NAL-NL2 fitting algorithm, which is an established prescription method in audiology, not typically "trained" on a specific dataset in the way a deep learning model would be. The document states NAL-NL2 is "widely used by hearing care professionals."

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

As mentioned above, the device uses the NAL-NL2 fitting algorithm. This algorithm itself is the "ground truth" for how the device determines personalized gain settings based on user input. The document mentions "NAL-NL2 is widely used by hearing care professionals to fit persons with mild to moderate hearing loss." The development and validation of NAL-NL2 as a prescriptive fitting formula involved extensive research and clinical studies by its developers (National Acoustic Laboratories, Australia) over many years, establishing its effectiveness and empirical basis in audiology rather than being a "training set" in the machine learning sense for this specific device. The device's self-fitting procedure then applies this established algorithm.

Summary

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On August 17, 2022, FDA issued a final rule establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. See here: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-overthe-counter-hearing-aids. The rule is effective October 17, 2022.

As part of this final rule, FDA amended the existing classification regulation for self-fitting air-conduction hearing aids, 21 CFR 874.3325, to identify these as hearing aids subject to the requirements in 21 CFR 800.30 or 21 CFR 801.422.

While the device submitted and cleared through K213424 may serve as a valid predicate device for a new self-fitting air-conduction hearing aid, please refer to the aforementioned final rule for current regulatory requirements for this device type.

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". The logo is simple and professional, and it is easily recognizable.

July 5, 2023

GN Hearing A/S Lars Hagander Head of Regulatory Governance & Intelligence Lautrupbjerg 7 Ballerup, DK-2750 Denmark

Re: K213424 Trade/Device Name: Jabra Enhance Plus Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QDD, QUH

Dear Lars Hagander:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 19, 2022. Specifically, FDA is updating this SE Letter to add the product code QUH. This change corresponds to the establishment of a regulatory category for over-the-counter hearing aids and related amendments to update the regulatory framework for hearing aids, as detailed in the final rule published on August 17, 2022 (see here for more information: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medicaldevices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids). This product code change is intended to better categorize your device consistent with the final rule. This an administrative change only and there is no impact on your 510(k) clearance.

For questions regarding this letter please contact Shu-Chen Peng, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, (301) 796-6481, shu-chen.peng@fda.hhs.gov.

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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Image /page/2/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. 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 agency's name in blue text.

January 19, 2022

GN Hearing A/S Lars Hagander Head of Regulatory Governance & Intelligence Lautrupbjerg 7 Ballerup, DK-2750 Denmark

Re: K213424

Trade/Device Name: Jabra Enhance Plus Regulation Number: 21 CFR 874.3325874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QDD Dated: October 19, 2021 Received: October 21, 2021

Dear Lars Hagander:

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/cfpm/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (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-devices/device-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 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

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Indications for Use

510(k) Number (if known) K213424

Device Name Jabra Enhance Plus

Indications for Use (Describe)

The Jabra Enhance Plus self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user's hearing needs. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K213424

Applicant Name and Address

Name	GN Hearing A/S
Address	Lautrupbjerg 7DK-2750 BallerupDenmarkTel: +45 4575 1111Fax: +45 4575 1119
Official Contact	Lars HaganderSenior Director of Regulatory, Governance & Intelligence, GNHearingTel: +45 4575 1111E-mail: lhagander@gnresound.com

January 19, 2022 Summary Preparation Date

Device name and Classification

Trade Name	Jabra Enhance™ Plus
Common/Usual Name	Self-fitting air-conduction hearing aid
Classification Name	Self-fitting air-conduction hearing aid
Regulation Number	21 CFR 874.3325
Product Code	QDD
Classification	Class II
Panel	Ear, Nose and Throat Devices
Predicate Device	Bose® Hearing Aid (DEN180026)

Device Description

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that has been paired with the earbuds. The controls accessible through the Jabra Enhance mobile app and on the earbuds are used to configure parameters, settings, and listening modes of the earbuds. The earbuds integrate a rechargeable 3.7V/15mAh li-ion battery coin cell inside each earbud, and they are recharged by the on-the-go charging case that also serves as a carrying case. The mobile app is connected to the Internet Services that enable remote upgrades to the earbud firmware in support of continued enhancements.

Figure 1 below illustrates the supported interactions and interfaces between the earbuds, the mobile app, the charging case, and the internet service.

Image /page/6/Figure/2 description: The image shows a diagram of the Jabra Enhance mobile app and its connection to other devices. The app connects to the internet services and earbuds via Bluetooth Low Energy. The earbuds connect to the charger via Bluetooth Low Energy and Galvanic connection, and they also use GN Proprietary Protocol.

Figure 1. Jabra Enhance Plus - System interactions and interfaces between components and the internet.

Intended Use

The Jabra Enhance Plus self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment.

Indications for Use

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device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

Self-Selection Labeling

Self-Selection labeling is included in the Jabra Enhance Plus IFU to mitigate the risk of improper self-selection. In summary, it addresses:

Identifying situations in which the Jabra Enhance Plus may help you hear better. ●
Identifying situations in which the Jabra Enhance Plus may not be right for the user. .
Identifying criteria that indicate the user should see a hearing professional. ●
. Informing the user that the Jabra Enhance Plus will not restore normal hearing.
Informing the user that it is good health practice to have hearing loss evaluated by an . appropriate healthcare professional.

Special Controls

The Jabra Enhance Plus conforms to the special controls stated in 21 CFR 874.3325. The Jabra Enhance Plus satisfied these requirements through:

Clinical data
Non-clinical performance testing ●
Human factors validation / Usability testing ●
. Labeling

Comparison of Technological Characteristics

The key similarities and differences between the Bose® Hearing Aid (predicate device) and the Jabra Enhance Plus (subject device) with respect to the technological characteristics are summarized in Table 1 below.

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EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
	Indications for Use	The Jabra Enhance Plus self-fittinghearing aid is intended to amplifysound for individuals 18 years ofage or older with perceived mild tomoderate hearing impairment. It isadjusted by the user to meet theuser's hearing needs. No pre-programming or hearing test isnecessary. The device is intendedfor direct-to-consumer sale and usewithout the assistance of a hearingcare professional.	The Bose Hearing Aid is intended toamplify sound for individuals 18years of age or older with perceivedmild to moderate hearingimpairment. It is adjusted by the userto meet the user's hearing needs. Nopre-programming or hearing test isnecessary. The device is intended fordirect-to-consumer sale and usewithout the assistance of a hearingcare professional.	The Indications for Use are thesame.
	Intended Use	The Jabra Enhance Plus self-fitting hearing aid is intended toamplify sound for individuals 18years of age or older withperceived mild to moderatehearing impairment.	The Bose Hearing Aid is intendedto amplify sound for individuals18 years of age or older withperceived mild to moderatehearing impairment.	The intended uses are the same.
Technological Characteristics
	Technology	Wireless, self-fitting air conductionhearing aid	Wireless, self-fitting air conductionhearing aid	Same as predicate
	Housing	In-ear hearing aid housing. Separateleft and right ear units (earbuds)with a user control push button oneach unit.Image: Two earbuds	Hearing aid neckband housing thatconnects to both the left and rightear units with user controls on rightearbud wire.Image: A neckband with earbuds	Although the subject devicehearing aid housing is wirelessand in-ear instead of a neckbandwith wired earbuds, the differencein housing does not raise differentquestions of safety oreffectiveness.Biological safety characteristicssame as predicate device.Nonclinical data from biologicalsafety testing and data from aclinical validation study supportsubstantial equivalence
	Wirelesscommunication	Wireless communication withhandheld device via Bluetooth	Wireless communication withhandheld device via Bluetooth	Same as predicate
AAMI TIR 69: 2017	Wirelesscoexistence	The GN Hearing Aid uses standard2.4GHz Classic Bluetooth andBluetooth Low Energy (BLE)standards to communicate betweenthe hearing aid and the user'sBluetooth enabled device. From therisk assessment, the temporary lossof Bluetooth communication frominterfering RF signals isappropriately considered anegligible risk and according toAAMI TIR 69, wireless coexistencetesting is not required. Note that theinterruption of device control fromthe App would be similar to whenthe user is separated from their	The Bose BMD-001 Hearing Aiduses standard 2.4GHz ClassicBluetooth and Bluetooth LowEnergy (BLE) standards tocommunicate between the hearingaid and the user's Bluetoothenabled device. From the riskassessment, the temporary loss ofBluetooth communication frominterfering RF signals isappropriately considered anegligible risk and according toAAMI TIR 69, wireless coexistencetesting is not required. Note that theinterruption of device control fromthe App would be similar to when	Same as predicate
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
		Bluetooth enabled device.	the user is separated from theirBluetooth enabled device.
	Wireless usercontrol functionsvia mobile app	Volume Control (-12dB to +6dB)Listen Mode (Surround, adaptive,focus)Preferred filter (full, normal, clear)	Volume controlModes (everywhere, front, focused)Tone correctionLeft/Right balance	Bose Hearing Aid allows forLeft/Right balance control,however Left/Right balance isachieved through the self-fittingprocess in the subject device andas such, is inherent in the self-fitted device.The additional Bose Left/Rightbalance does not raise differentquestions of safety oreffectiveness.Nonclinical data from a formativeusability study and data a clinicalvalidation study supportsubstantial equivalence.
	Demonstrate thathearing Aid deviceinitiates Bluetoothpairing, andBluetooth controland streamingfunctionality	Pairing, control, streamingverification with the paired mobiledevice.	Pairing, control, streamingverification with the paired mobiledevice.	Same as predicate
	Battery	Hearing Aid with a single cellrechargeable 3.7V/15mAh li-ionbattery coin cells inside eachearbud.	Hearing Aid with a single cellrechargeable 3.7V/270mAh li-ionbattery inside neckband.	While battery capacity isdifferent, both devices arerechargeable and allow for 10hours of battery life on a fullcharge, and as such the differencein battery capacity does not raisedifferent questions of safety oreffectiveness.Nonclinical data from batterysafety testing and data from a
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
	Charging	Jabra Enhance Plus hearing aids,are charged in a proprietary On-The-Go charging case via aphysical connection through Pogocontact pins in the charging case.The charging case itself contains asingle cell 3.7V/129mAh li-ionbattery that allows the user tocharge the earbuds on-the-gowithout the need for beingconnected to a power outlet.The charging case supports bothself-powered operation and/orbeing powered by a standard USBcable connected to a power supply.When connected to a USB powersupply, the internal battery isrecharged, allowing for future on-the-go charge of the earbuds.	Hearing aid is charged via USBcable connected to a power supplyand to the neckband where therechargeable battery source islocated.	clinical validation study supportsubstantial equivalence.Charging the subject devicehearing aids in a portablecharging case with or withoutconnecting the charging case to apower supply via a USB cabledoes not raise different questionsof safety or effectiveness.Non-clinical data from aformative usability study supportsubstantial equivalence.
	Microphones	Microphones in earbuds may,during use, be configured by theuser in omnidirectional ordirectional modes,Surround, adaptive, focus.	Microphones in earbud may, duringuse, be configured by the user inomnidirectional or directionalmodes, everywhere, front, focused.	The subject device as well as thepredicate device allow foromnidirectional and speech focusoptions.The subject device supports anadaptive directional mode thatallows the earbuds to determinethe most suitable directionality forthe microphones for the givenenvironment.The added automatic selection ofdirectionality does not raisedifferent questions of safety oreffectiveness.
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
				Directional Microphone optionswere made available to the studyparticipants during the field trialas also was done for the predicatedevice.Slight differences in thedirectional microphoneparameters between subject andpredicate device do not impact thestudy population.Clinical data from peer-reviewedliterature (Wu et al. Ear Hear.2019) and a clinical validationstudy support substantialequivalence.
	Device control	On-Device user controls:- Volume up/downmicrophone- Volume up/downstreaming- Mute- Answer mobile call- End or reject mobile call	On-Device user controls:- Volume up/downmicrophone- Volume up/downstreaming- Power on/off button- BlueTooth pairing button	Sound adjustment features onpredicate and subject devices areidentical.Jabra Enhance Plus furthersupports mobile phone callcontrols.Bluetooth pairing mode is enteredwhen the earbuds are removedfrom the charging case.The added call controls anddifferent means of engagingBlueTooth pairing do not raisenew questions for safety oreffectiveness.
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
				Nonclinical data from asummative usability study anddata from a clinical validationstudy support substantialequivalence.
	Compression	17 channel wide band dynamicrange compression	12 channel wide band dynamicrange compression	The 5 additional channels on thesubject device, as they are lumpedinto base, mid and treble and offersimilar spectral tilt as predicatedevice. The 5 additional channelsdo not raise different questions ofsafety or effectiveness.Data from a clinical validationstudy support substantialequivalence.
	Noise reduction	Steady-state noise reduction, wherebackground noise is filtered outfrom sound occurring at themicrophones.Impact noise control.No support for activenoise reduction.	Active noise reduction.Impact noise control.	Subject device does not supportadaptive noise cancellation likepredicate device, however thesubject device incorporates thesame algorithms already proveneffective in products released tothe market by GN Hearing, likePrimary DI Number05708296195077, exempt frompremarket notification.While differences in theimplementation of noisecancellation exist, the methodsdeveloped by GN Hearing haveproven effective in productsalready on the market, andtherefore do not raise differentquestions of safety oreffectiveness
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
				Noise reduction features wereavailable to the study participantsduring the field trial as also wasdone for the predicate device.Slight differences exist in thenoise reduction parametersbetween subject and predicate
				device but do not impact the studypopulation.Clinical data from peer-reviewedliterature (Wu et al. Ear Hear.2019) and a clinical validationstudy support substantialequivalence.
	Feedbackcancellation	Feedback canceller.	Feedback canceller.	Same as Predicate
	Telephone calls	Placing and receiving telephonecalls.	Placing and receiving telephonecalls.	Same as Predicate
	Mobile App	Same as Predicate with respect toiOSNot compatible with Android.	Mobile application, on handhelddevice (iOS or Android) used toconfigure parameters, settings, andlistening modes.	The lack of compatibility withhandheld Android devices doesnot raise different questions ofsafety or effectiveness.
				Nonclinical data from asummative usability study anddata from a clinical validationstudy support substantialequivalence.
	Self-fitting method	Apply personalized gain settingsbased on user input and Fine-Tuning.Utilizes the validated NAL-NL2fitting algorithm.	Loudness and Fine-Tuning.Utilizes a proprietary fittingalgorithm.	Subject device uses a validatedNAL-NL2 fitting algorithminstead of a proprietary algorithmas used by the predicate device.NAL-NL2 is widely used byhearing care professionals to fitpersons with mild to moderatehearing loss.
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
				Legally marketed hearing aidsexempt from 510(k) also embedthe NAL-NL2 fitting algorithm,but these exempt hearing aids arefitted by hearing careprofessionals.As such the difference in fittingdoes not raise different questionsof safety or effectiveness.Data from a clinical validationstudy support substantialequivalence.
	Remote Firmwareupdate	The Jabra Enhance app allows forremote firmware update of theearbuds via the Cloud.	Unknown	Remote firmware update allowsGN to maintain and improve theJabra Enhance Plus andcontinuously strengthencybersecurity as new mobileoperating systems are released.Allowing for Remote FirmwareUpdates is assessed as part of thecybersecurity risk process, andrisk mitigations are developed perthe device hazard analysis, andcybersecurity associated with theRFU internet service.Patient risks associated withRFUs are understood, mitigatedand the subject device isconsidered safe. This feature doesnot raise different questions ofsafety or effectiveness.Nonclinical data documented inthe cyber risk register support
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
Exposure to nonionizing radiation				substantial equivalence.
Special control 5i	Exposure tononionizingradiation	Passes according to:IEC 62479:2010And deemed sufficiently safe interms of human exposure tononionizing radiation exposure.	The Bose Hearing Aid contains aBluetooth radio transmitteroperating in the ISM band (2.400 to2.4835 GHz) at less than 10 mWEIRP. The output power level atthese operating frequencies of theBose Hearing Aid was deemedsufficiently safe in terms of humanexposure to nonionizingradiationfor the intended use.	Comparable to predicateUses same Bluetooth technology.Nonclinical data from verificationtesting in accordance with IEC62478:2010 (human exposure toelectromagnetic fields) supportsubstantial equivalence.
Electroacoustic performance
Special control 2ANSI/CTA 2051-2017 and underlyingANSI S3.22-2014	Electroacousticcharacteristics	Frequency range: 100-8700 Hz.Maximum output (90 dB SPLinput): 110 dB SPL.Equivalent noise input level: 26dBHFA Full-On-Gain (50 dB SPLinput): 25 dBLatency: <15msTHD@500Hz: 0.4%THD@800Hz: 0.4%THD@1600Hz: 1.0%THD@3200Hz: 0.3%Per ANSI S3.22-2014 - 2cc couplerHigh Frequency Average (HFA)per ANSI S3.22-2014 definition,the average of gain or SPL indecibels at 1000, 1600 and 2500Hz.	The specifications below are asreported in Sabin et al., 2020(published results of predicatedevice clinical study that supportedthe Bose De Novo Request,DEN180026):Frequency range: 200-8000 HzMaximum output (90 dB SPLinput): 115 dB SPLEquivalent noise input level:26dBInsertion Gain Targets (50dB SPLinput) at 4000 Hz: rangefrom 15- 35 dB (from Figure 4in Sabin et al.) (Per ANSI/CTA2051-2017).	Comparable to predicate andsuitable for the intended user:ANSI/CTA 2051-2017 usesmeasurement methods and 2cccoupler from ANSI S.3-22 and assuch, the frequency range,maximum output & equivalentnoise input level can be compareddirectly to predicate device.Total harmonic distortion (THD)and latency meet requirements ofANSI/CTA 2051-2017, withrequirements of <5% and <15msrespectively. Direct comparison tothe predicate device is notpossible as performance ofpredicate device on theseparameters are not publiclyavailable.The latency and total harmonicdistortion meet the requirementsin ANSI/CTA 2051-2017 of
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
ANSI/ASA S3.22-2014 (6.8)	FrequencyResponse (Gain)	Image: Graph of Frequency Response (Gain) for Jabra Enhance Plus	Image: Graph of Frequency Response (Gain) for Bose Hearing Aid	<15ms and <5% respectively, andas such do not raise differentquestions for safety oreffectiveness.Nonclinical data from testing inaccordance with ANSI/CTA 2051support substantial equivalence.
ANSI/CTA2051:2017 (4.1) withunderlying testmethod ANSIS3.22:2014 (6.9)per DEN180026	FrequencyResponseBandwidth	100Hz to 8700Hz	At least 250 Hz - 5 kHz	Same as predicate
ANSI S3.22:2014(6.2)per DEN180026	Acoustic Output dBSound pressureLevel at input 90dB Sound pressureLevel(OSPL 90)	Image: Graph of Acoustic Output dB Sound pressure Level at input 90 dB Sound pressure Level (OSPL 90) for Jabra Enhance Plus	Image: Graph of Acoustic Output dB Sound pressure Level at input 90 dB Sound pressure Level (OSPL 90) for Bose Hearing Aid	Comparable to predicate andsuitable for the intended user.Adequate for fitting mild tomoderate hearing loss asprescribed by NAL-NL2.Specification of hearing aidcharacteristic and testing both inaccordance with ANSI S3.22,support substantial equivalence.
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
ANSI S3.22:2014(6.2)per DEN180026	Maximum AcousticOutput SoundPressure LevelInput 90dB SPL(Max OSPL90)	110 dB SPL which is less than orequal to 120 dB SPL	115 dB which is less than orequalto 120 dB SPL.	Same as predicate
ANSI S3.22:2014(6.11) perDEN180026	HarmonicDistortion(Output Distortion)	Total Harmonic Distortion (THX)THX 500 Hz 0,4%THX 800 Hz 0,4%THX 1600 Hz 1,0%THX 3200 Hz 0,3%Results are less than 5%	Less than or equal to 5%	Same as predicate
ANSI/CTA2051:2017 (4.4.2) perDEN180026Test frequency = 500Hz Test input level =100 dB SPL Gainadjusted for output =80 dB SPL or, if notpossible, for 100 dBSPL	Input Distortion	3,5 % which is less than 5%	Less than or equal to 5%	Same as predicate
ANSI S3.22:2014(6.12) perDEN180026	Equivalent InputNoise(EIN)	24 dB SPL which is less than orequal to 32 dB SPL	26 dB SPL which is less than orequal to 32 dB SPL	Same as predicate
ANSI/CTA2051:2017 (4.8) perDEN180026	Latency	5.6 ms which is less than 15 ms	Less than or equal to 15 ms	Same as predicate
ANSI S3.22:2014(6.3) per DEN180026	High FrequencyAverage OutputSound PressureLevel(HFA OSPL 90)	104 dB SPL	112 dB SPL	Adequate for fitting mild tomoderatehearing loss asprescribed by NAL-NL2.Data from a clinical validationstudy support substantialequivalence.
ANSI S3.22:2014(6.5) per DEN180026	High FrequencyAverage Full OnGain (HFA FOG)	26 dB	43 dB	Adequate for fitting mild tomoderatehearing loss as
EvaluationCriterion	Characteristic	Jabra Enhance Plus(Subject Device)	Bose Hearing Aid(Predicate Device)	Discussion
				prescribed by NAL-NL2.Data from a clinical validationstudy support substantialequivalence.
ANSI S3.22:2014(6.7) per DEN180026	Reference TestGain (RTG)	25 dB	36 dB	Adequate for fitting mild tomoderatehearing loss asprescribed by NAL-NL2.Data from a clinical validationstudy supports substantialequivalence.
ANSI/CTA2051:2017 (4.10 –4.17) perDEN180026	-Fixed or LevelDependentFrequencyEqualization -Tone-Control LevelDependentGain/Compression-SNR Enhancement-Noise Reduction-Feedback Control /Cancellation-PersonalizationDevice-Coupling to theEar-WirelessConnectivity	Hearing Aid Features reported.	Hearing Aid Features reported.	Same as predicate.

Table 1. Key Similarities and Differences betwen the Bose® Hearing Aid (Predicate Device) and the JabraEnhance Plus (Subject Device).

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The results of all performance testing required as special controls demonstrated substantial equivalence of the Jabra Enhance Plus to the predicate Bose Hearing Aid. The Jabra Enhance Plus has the same intended use and fundamental technology as the predicate, the Bose Hearing Aid (DEN180026). The differences in technological characteristics do not raise different questions of safety or effectiveness.

While the proposed predicate and subject device are not identical, the technological characteristics are similar and the technological differences between the proposed predicate device and the subject device do not raise different questions of safety and effectiveness. Table 1 above identifies each of the key technological differences between the Jabra Enhance Plus and the predicate device as well as the accepted scientific testing performed for each of these differences to demonstrate substantial equivalence. The non-clinical, usability, and clinical performance testing demonstrated substantially equivalent safety and effectiveness of the Jabra Enhance Plus as compared to the predicate device.

Non-clinical Performance Testing

GN Hearing A/S conducted performance testing on the Jabra Enhance Plus to provide reasonable assurance of safety and effectiveness of the subject device as compared to the predicate device, Bose Hearing Aid (DEN180020). The standards used for non-clinical Performance testing are listed below.

Electrical safety testing is performed according to IEC 60601-1:2005+A1:2012+A2:2020, . IEC 60601-2-66:2019, IEC 60601-1-11 Edition 2.0 2015-1, IEC 62133-2 Edition 1.0 2017-02 and IEC 62368-1:2018/COR1:2020.
Electromagnetic compatibility (EMC) testing is performed according IEC 62479:2010, ANSI ● IEEE C63.19-2019 and IEC 60601-1-2:2014+A1:2020.
. Radio and Telecommunication testing is performed to be in compliance with applicable parts of the FCC rules in title 47 of the CFR.
. Electroacoustic testing is performed according to ANSI/ASA S3.22-2014 and ANSI/CTA 2051:2017.

Software was developed, tested and documented in accordance with "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005) for a Moderate Level of Concern and with "Content of premarket Submissions for Management of Cybersecurity in Medical Devices" (Draft issued October 18, 2018).

Usability Engineering was performed in compliance with IEC 62366-1:2015.

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Biocompatibility

The Jabra Enhance Plus Earbuds were tested in accordance with ISO 10993-1, FDA Guidance

"Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

The relevant biological endpoints were checked by testing the earbuds including the EarGels in their final finished form: MTS Cytotoxicity Test (ISO 10993-05:2009) , Guinea Pig Maximization Sensitization Test (ISO 10993-10:2010), Intracutaneous Study in Rabbits (ISO 10993-10:2010).

For the Charging Case, Model C-5 biological evaluation was performed in accordance with the FDA Guidance noted above and also the FDA draft guidance "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin".

Results

The Jabra Enhance Plus Earbuds passed all tests for the relevant non-clinical performance testing and biological endpoints, namely cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO 10993-10:2010). Similarly, usability testing and software verification and validation demonstrated mitigation of risks to an acceptable level as well as reasonable assurance of safe and effective device performance. Usability testing is discussed in more detail below.

Conclusion

Based on the results of the non-clinical performance testing and the risk management acctivities, the device system. Jabra Enhance Plus, is safe and meets performance specifications. It is also biologically safe for the user. Overall, these results, together with results from usability testing and software verification and validation, further support the risks to health are mitigated to an acceptable level and provide additional evidence of safety and effectiveness.

Clinical Data

A clinical validation study was conducted across two geographically disparate U.S. clinical audiology sites. Subjects, aged 28 to 73 years, ½ male and ½ female, were fitted bilaterally with prototype Jabra Enhance Plus hearing aids. About 66% (25/38) of the subjects had never worn hearing aids before. Study criterion was mild to moderate bilateral sensorineural hearing loss (from 250 through 8000 Hz with at least one threshold >20 dB HL and thresholds at 500. 1000. 2000 and 4000 Hz < 55. 65. 70. and 80 dB HL, respectively). Individual audiograms covered the range from very mild/near normal to moderate/bordering on severe. Mean and standard deviation audiograms for each ear were very similar to those in the predicate Bose self-fitting hearing aid study'.

Protocol

An in-lab session examined reliability of the device's self-fitting method (SELF-FIT) and compared it to a best-practices professional fitting of the same device (PRO-FIT). For SELF-FIT, each subject performed the procedure twice (SELF-FIT A and B). Based on hearing estimates obtained through the

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device's "heard it" procedure, the device software internally set gain, frequency response, and compression using an algorithm based on the NAL-NL2 prescription'. For PRO-FIT, an audiologist fit the same device using in situ NAL-NL2 real ear aided response (REAR) targets. In the predicate Bose device study , NAL-NL2 was also used for the comparison. Unaided responses on a speech-in-noise test (QuickSIN') and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaires were obtained as a baseline for later aided measurements.

Subsequently, a cross-over, within-subject (repeated measures) wear-time field trial was used to evaluate validity of the self-fitting method and hearing device in terms of effectiveness in everyday use. At the end of the in-lab session, one-half of the subjects at each site wore the devices programmed with SELF-FIT (A) settings and the other half wore home the same devices programmed with PRO-FIT. After 10-14 days, subjects returned to the clinic for aided outcome measurements (QuickSIN, APHAB). Then the devices were set to the other fitting and worn another 10-14 days, followed by a return to the clinic for aided measurements with the second fitting. Subjects were blinded as to which fitting was being worn. Device settings available for the subjects to adjust with the app were those that will be on the commercial hearing aid, including overall volume, frequency response ("spectral tilt") options, and microphone directionality. This is similar to adjustability offered in the predicate Bose device study and offers fine-tuning options typical for the candidate mild to moderate hearing losses.

Effectiveness Results

Data were obtained for the initial in-lab session on 38 subjects (19 at each site). The primary endpoint for this session was REAR results. Statistical analysis revealed equivalence between SELF-FIT A and B for the replicated REAR4 (500, 1000, 4000 Hz) for both ears, indicating excellent reliability of the self-fitting test method. In terms of the fit to NAL-NL2 targets, analysis of REAR4 revealed that neither SELF-FIT A nor B was statistically equivalent to PRO-FIT within the symmetric equivalence region of ±2.5 dB difference. The greatest REAR deviation for both SELF-FIT and PRO-FIT was in the higher frequencies, as is typical in hearing aid fittings, but underfitting to target was somewhat greater for SELF-FIT, especially at 4000 and 6000 Hz. When the average REAR measure was computed based on 500, 750, 1000, 1500 and 2000 Hz (frequencies most critical for speech understanding), the difference between SELF-FIT A and PRO-FIT was reduced about 1 dB on average. Further, the root-mean-square difference from target calculated for those frequencies showed no significant difference between SELF-FIT A and PRO-FIT for the right ear, although the mismatch to target for SELF-FIT was still greater than that for PRO-FIT for the left ear. Self-fit gain was also less than professionally fit in the Bose predicate device study1.

Despite less high-frequency gain supplied by the SELF-FIT method than PRO-FIT, statistical analysis revealed equivalence (within ± 1.5 dB) of QuickSIN scores (the secondary endpoint) across all three fitting conditions (SELF-FIT A and B, and PRO-FIT). This result indicates both validity and reliability of the self-fitting method on this performance measure.

For the wear-time field trial, complete data were obtained on 37 subjects (18 at one site and 19 at the other). The objective was to confirm that performance outcomes for the SELF-FIT condition were not inferior to those from the same devices fit by an audiologist (PRO-FIT) after a period of hearing-aid use in everyday conditions. The primary endpoint was the APHAB-global score. Results showed very similar aided mean and standard deviation values for SELF-FIT and PRO-FIT across APHAB subscales and the overall APHAB-global score. On two of the three subscales assessing speech communication (RV and BN) and the global score, mean scores were significantly improved over the unaided condition for both SELF-FIT and PRO-FIT. Analysis of the APHAB-global score revealed that SELF-FIT was

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statistically non-inferior to PRO-FIT. Further, APHAB-global scores for SELF-FIT and PRO-FIT were nearly identical to those reported in the Bose predicate device study'. Using a custom 7-point scale, most subjects reported that they believed both the SELF-FIT and PRO-FIT conditions enhanced their listening on the telephone (58%; 19/33) and to music (67%; 22/33).

Mean and standard deviation QuickSIN scores after the trials (the secondary endpoint) also showed similar values between SELF-FIT and PRO-FIT. Performance with SELF-FIT was statistically non-inferior to that with PRO-FIT. The QuickSIN results showed essentially the same trends as those reported for the Bose predicate device study1.

Safety results

The safety endpoint of the clinical validation study was met. There were no recorded Adverse Events (AEs) or Serious Adverse Events (SAEs) at either study site during the study.

Discussion and Summary

Repetition of the self-fitting procedure resulted in statistically equivalent REAR and QuickSIN results. These findings, together with strong and sigmificant test-retest correlations, provide evidence that the self-fitting procedure for the Jabra Enhance Plus hearing aid is very reliable.

The SELF-FIT method did result in some underfitting to NAL-NL2 REAR targets on average relative to PRO-FIT, particularly in the higher frequencies. While it would not have been detrimental if SELF-FIT had provided more gain. the observed REAR acoustical differences between the two fitting methods were ultimately inconsequential to performance, as evidenced by good functional and field trial results. It is well known that a wide range of aided frequency responses can vield equivalent speech-in-noise performance in adults with mild to moderate hearing loss'. Performance when wearing the device home is considered paramount because it is more clinically meaningful than measures completed during a bref in-lab session. The field-trial data in this study illustrated both measurable and perceived benefit of the self-fitted devices. Further, other studies have also observed a preference for self-fit gain to be lower than that prescribed by NAL-NL2, especially in the higher frequencies 1607. Finally, the REAR differences between SELF-FIT and PRO-FIT in this study were within a range that could be readily compensated for by adjustments of device volume or spectral tilt using the app if the self-fitted user later prefers more gain or high-frequency emphasis.

In summary, the evidence from the clinical validation study taken as a whole provide strong support for the conclusion that the Jabra Enhance Plus hearing aid has a reliable self-fitting method and will provide the intended population of adults with mild to moderate hearing loss with functional performance that is not inferior to that provided by a professional hearing aid fitting. The findings of this clinical trial are similar to those from the Bose predicate device study .

References

1. Sabin A, Van Tasell B, Rabinowitz B, Dhar S (2020). Validation of a self-fitting method for over-the-counter hearing aids. Trends in Hearing 24: 2331216519900589.
Keidser G, Dillon H, Flax T, et al. (2011). The NAL-NL2 prescription procedure. Audiol Research 1. 2.
Killion M, Niquette P, Gudmundsen G, et al. (2004). Development of a quick speech-in-noise test for measuring signal-3. to-noise ratio loss in normal-hearing-impaired listeners. J Acoust Soc Am 116: 2395-2405.
Cox R, Alexander G. (1995). The Abbreviated Profile of Hearing Aid Benefit (APHAB). Ear Hear 16: 176-186. 4.
Van Buuren, R, Festen J, Plomp R. (1995). Evaluation of a wide range of amplitude-frequency responses for the hearing ട.

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impaired. J Speech Lang Hear Res 38: 211-221.

1. Humes L, Rogers S, Quigley T, et al. (2017). The effects of service-delivery model and purchase price on hearing-aid outcomes in older adults: A randomized double-blind placebo-controlled clinical trial. Am J Audiol 26: 53-79.
Urbanski D, Hernandez J, Oleson J, Wu Y-H (2021). Toward a new evidence-based fitting paradigm for over-the-counter 7. hearing aids. Am J Audiology 30: 43- 66.

Human Factors / Usability Testing

The Jabra Enhance Plus meets the applicable requirements of IEC62366:2015 Medical devices -Application of usability engineering to medical devices.

Usability was evaluated in two formative usability studies and a summative usability study. Based on the results of the initial, internal formative Pre-Alpha 1 usability study and a subsequent, external formative usability study, the following changes were made before conducting the summative usability study:

. Updated pairing scheme in earbud firmware
. Face card with quick start guide placed in the box is updated both on the front and back
Earbud/charging case improvements .
. App improvements

Human factors validation testing performed was a summative usability test conducted for the purpose of evaluating safety and ease-of-use of the earbud and associated materials, i.e., software, instructions for use, and packaging, to identify any residual risks and propose any opportunities for improvements of the device's user interface. The summative usability study was divided into two parts, one that evaluated whether 21 participants who were not intended device users could use the external packaging and labeling to ascertain the device's contraindications, and a second functional usability study that evaluated whether 15 intended users (i.e., those with mild-moderate hearing loss) primarily to assess their ability to set-up the earbuds. The results of the testing were used to improve the Jabra Enhance Plus to a level found sufficient to conclude that the residual risk is low and has been reduced to an acceptable level. Furthermore, the residual risk mitigation measures are described in the user manual in the form of cautions and warnings.

The Jabra Enhance Plus has been found to be safe and effective for the intended users, uses, and use environment.

Substantial Equivalence

The Jabra Enhance Plus has the same intended use and fundamental technology as the predicate, the Bose Hearing Aid (DEN180026). The differences in technological characteristics, summarized in Table 1 above, do not raise different questions of safety or effectiveness. For each of these technological differences, Table 1 also summarizes the accepted scientific testing performed to demonstrate substantial equivalence. Non-clinical performance testing

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demonstrated equivalent safety and effectiveness with respect to electrical safety, EMC, radio/telecommunications and electroacoustic testing. Similarly, software was developed, tested, and documented in accordance with "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005) for a Moderate Level of Concern and with "Content of premarket Submissions for Management of Cybersecurity in Medical Devices" (Draft issued October 18, 2018). The usability testing and clinical study provided validation that risks to health have been mitigated to an acceptable level as well las reasonable assurance of safety and effectiveness and evidence of clinically meaningful benefit to a population experiencing obstacles to accessibility and affordability of hearing aids. 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 Jabra Enhance Plus clearly outweigh the potential risks to health. Thereby, the performance data taken as a whole, demonstrate that the Jabra Enhance Plus is substantially equivalent to the Bose Hearing Aid with respect to safety and effectiveness.

Conclusion

The Jabra Enhance Plus is substantially equivalent to the predicate device, i.e., the Bose Hearing Aid (DEN180020) with respect to the indications for use, intended use and technological characteristics. The Jabra Enhance Plus is as safe and as effective as the predicate device for its intended use when used according to the 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.