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The Self-Fitting hearing aids are intended to amplify sound for individuals 18 years of age or older with to moderate hearing impairment. They are adjusted by the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

Per 21 CFR 874.3325, a self-fitting wireless 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. Self-fitting wireless air conduction hearing aids are Class II medical devices. The Self-Fitting hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with domes. Self-Fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow the user to adjust volume setting and customize the hearing mode program.

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

Acceptance Criteria and Device Performance for Self-Fitting Hearing Aids (K221052)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Clinical Test Set Sample Size: 36 subjects were initially enrolled, but 6 withdrew, resulting in 30 subjects for analysis. The document states the planned minimum was 32 subjects.
• Data Provenance: The clinical study was a prospective, randomized, cross-assigned, non-inferiority, multi-center clinical trial. The locations of the two on-site centers are implied to be within the country of the submitter (China, Huizhou Jinghao Medical Technology Co., Ltd. and Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.), though not explicitly stated for the subjects' origin.

3. Number and Qualifications of Experts for Ground Truth:

• For the Pro-fit condition, which serves as a comparison to the self-fit device, the text refers to "audiological best practice hearing aid fittings." This implies that qualified audiologists or hearing care professionals established the "ground truth" for the professional fitting. The number and specific qualifications of these experts are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set:

• The study design was a randomized, cross-assigned, non-inferiority, multi-center clinical trial. Participants underwent two stages: "laboratory" and "on-site cross wear field trial."
• Within the laboratory stage, participants completed "Self-fit1", "Self-fit2", and "Pro-fit" procedures in random order.
• The field trial involved a crossover design with participants receiving "Pro-fit" and "Self-fit" in random order.
• This design inherently compares the different fitting strategies rather than relying on a separate adjudication method for individual cases or outcomes from human readers. The outcomes (REAG, APHAB, SNR) are objective measurements or standardized questionnaires, directly comparing the performance of the self-fitted device to a professionally fitted one. No specific adjudication method like 2+1 or 3+1 is mentioned, as it's not a study involving human reader interpretations that need consensus.

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 for image interpretation. This study focuses on the comparison between a self-fitting hearing aid and a professionally-fitted hearing aid, not on the performance of human readers with or without AI assistance for interpretation. Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• Yes, a standalone performance study was conducted in the sense that the "Self-fit" condition represents the algorithm's performance without direct intervention from a hearing care professional during the fitting process by the user. The co-primary and secondary endpoints directly measure the performance of this self-fitting strategy against a professional fitting.

7. Type of Ground Truth Used:

• For the clinical study, the "ground truth" or reference for comparison was established by:
  • Audiological Best Practice Hearing Aid Fittings (Pro-fit): This involved a professionally conducted fitting, likely by qualified audiologists, measuring Real Ear Aided Gain (REAG) and collecting data on Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Recognition Threshold in Noise (SNR). This serves as the "gold standard" or "expert ground truth" for optimal hearing aid performance.
  • Repeated Self-fitting Measurements (Self-fit1 vs. Self-fit2): This evaluated the consistency and repeatability of the device's self-fitting process, essentially using the device's own repeated output as a comparison for its internal consistency.

8. Sample Size for the Training Set:

• The document describes a clinical validation study for effectiveness and safety. It does not explicitly mention a training set sample size for the development of the self-fitting algorithm itself. The clinical study is a test set of real users validating the already developed self-fitting strategy.

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

• Since there's no explicit mention of a training set or its sample size, there's no information provided on how ground truth for a training set was established. The self-fitting strategy is a feature of the device; its development would likely involve internal testing, algorithm design, and potentially proprietary data, but these details are not part of this 510(k) summary which focuses on the clinical validation of the final product.

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