(183 days)
The MDHearing Smart Hearing Aids are self-fitting air-conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are 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 MDHearing Smart Hearing Aid is a self-fitting wireless air conduction hearing aid system consisting of the Intricon Lumen 200B hardware and the MDHearing mobile application, which is an "app" compatible only with MDHearing devices of a Smart Hearing Aid product line, designed to interface with a user's compatible smartphone or tablet to personalize and manipulate the device and its settings. The wireless hearing aid incorporates microphones and a receiver encased in the behind-the-ear (BTE) hearing aid body, delivering amplified sound to the ear via standard thin tubing coupled to an earpiece for audio input into the ear. The hearing aid can be controlled wirelessly via Bluetooth Low Energy® using the MDHearing app or manually with on-device push buttons for changing volume and programs. The controls accessible through the MDHearing app and on the hearing aids are used to configure parameters, settings, and listening modes of the devices. The MDHearing Smart Hearing Aid is powered by a standard disposable size 312 zinc-air hearing aid battery.
The provided text describes the MDHearing Smart Hearing Aid and the studies conducted to demonstrate its substantial equivalence to a predicate device (Bose® Hearing Aid). The primary focus of the clinical performance testing was to show that self-fitting the device produced outcomes non-inferior to a professional fitting.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The clinical performance validation aimed to demonstrate non-inferiority of the self-fit MDHearing Smart Hearing Aid compared to the same device professionally fit. The primary test metrics were user-reported (subjective) aided benefit using two standard questionnaires: the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the 12-item short form of the Speech, Spatial and Qualities of Hearing scale (SSQ12). A secondary metric was speech-in-noise recognition using the QuickSIN test.
The text states: "The study results demonstrated that the MDHearing Smart Hearing Aid was non-inferior to fitting by a hearing care professional for both subjective and objective measures of hearing aid benefit."
The specific acceptance criteria (e.g., non-inferiority margins) are not explicitly stated as numerical thresholds in this document, but the graphical representations (Figure 2b and Figure 3b) show confidence intervals relative to a non-inferiority margin (-δ). The conclusion is that these intervals did not extend beyond the non-inferiority boundary.
Table of Acceptance Criteria and Reported Device Performance (Summary based on text):
| Acceptance Criteria (Implicit from study design for Non-Inferiority) | Reported Device Performance |
|---|---|
| Primary Endpoints: | |
| Non-inferiority of Self-Fit vs. Professional-Fit on Subjective Aided Benefit (APHAB Global Benefit Scores) | Mean scores and distributions comparable between self-fit and professional-fit groups. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 2a and 2b) |
| Non-inferiority of Self-Fit vs. Professional-Fit on Subjective Aided Benefit (SSQ12 Benefit Scores) | Mean scores and distributions comparable between self-fit and professional-fit groups. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 2c and 2d) |
| Secondary Endpoints: | |
| Non-inferiority of Self-Fit vs. Professional-Fit on Speech-In-Noise Recognition (QuickSIN) | No difference in speech-in-noise intelligibility benefit between self-fit and professional-fit groups, with subjectively comparable score distributions. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 3a and 3b) |
| Reliability of self-fitting method (Probe-Microphone Real Ear Measures - REAG) | Mean absolute difference (MAD) in real-ear measures of average gain significantly less than 2 dB (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.