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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.

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.

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.

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.

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