(182 days)
The Vibe SF seff-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 through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The EasyFit self-fitting web application is intended to support self-fitting and fine-tuning of the Vibe SF hearing aid.
The Vibe SF Self-Fitting Hearing Aid ("Vibe SF") is a self-fitting air conduction hearing aid 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.
The Vibe SF hearing aid is based on WSAUD's wireless hearing aid series Signia Silk 1X (regulated under 21 C.F.R. § 874.3305). However, unlike standard wireless air-conduction hearing aids, the Vibe SF is intended to be sold directly to the end-user without involvement of a hearing care professional. Briefly, the self-fitting hearing aid system consists of two components:
- a) A wireless hearing aid with a self-fitting feature (Vibe SF); and
- b) A mobile web application (EasyFit) to support the self-fitting and fine-tuning of the hearing aid.
The Vibe SF wireless hearing aid hardware includes: Ear pieces (click sleeves), housing, circuit board, battery, chip, and electroacoustic components. The subject device is fitted for bilateral use with a left and right device. Left and right hearing aids are able to communicate with each other over a magnetic inductive wireless link. The instant fit in-the-ear (ITE) style of the Vibe SF hearing aid uses Click Sleeves in 4 different sizes to couple with the ear canal. The hearing aids are marked with 'R' for right and 'L' for left, and are powered by standard (non-rechargeable) Zinc-Air batteries (size 10A). The Vibe SF hearing aid includes software that communicates with the EasyFit app to provide self-fitting functionality.
The Vibe SF is fitted by the user through the EasyFit self-fitting web application, which is run on an Internet browser on the user's mobile device (smartphone or tablet with iOS or Android operating system). The EasyFit self-fitting web application guides the user through the selffitting procedure and also allows the user to set audiological gain parameters and preferred settings on the Vibe SF Hearing Aid. In addition, a software application (app for iOS and Android) called Vibe app is available as remote control for adjusting volume during daily use.
Here's a breakdown of the acceptance criteria and study details for the Vibe SF Self-Fitting Hearing Aid, based on the provided text:
Acceptance Criteria and Reported Device Performance
The primary objective of the clinical study was to demonstrate non-inferiority of the Vibe SF self-fitting strategy compared to an audiologist-fit (HCP fit) strategy regarding perceived hearing aid benefit. This was measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) subscales for ease of communication (EC), background noise (BN), and reverberant room (RV).
The acceptance criterion for effectiveness was simultaneous non-inferiority on all three APHAB subscales.
| Acceptance Criterion (Effectiveness) | Reported Device Performance |
|---|---|
| Non-inferiority of Vibe SF self-fitting strategy compared to HCP-fit strategy on all three subscales of APHAB (EC, BN, RV). | Achieved. The Vibe SF strategy was non-inferior to the HCP fit strategy in each of the 3 benefit scores for each subscale in the APHAB (**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.