(532 days)
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:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Non-Inferiority Margin) | Reported Device Performance (Confidence Interval / P-value) |
|---|---|---|---|
| Co-Primary Endpoints | REAG (Self-fit vs. Pro-fit) at 500Hz, 1000Hz, 2000Hz, 4000Hz (Lab) | -2.5 dB (non-inferiority margin) | - Right Ear: |
| 500Hz: (-1.7976, 0.8933), P |
§ 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.