(147 days)
The Bose 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 Bose® Hearing Aid is a user-fitted wireless air-conduction hearing aid intended for use by individuals 18 years of age and older with perceived hearing impairment. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth® using a handheld device (iOS or Android) through the Bose Hear mobile app. There is an on-device user control (in-line remote) on the right cable (attached to neckband) that allows separate control of hearing aid ("world") volume and streaming audio volume, as well as control of directional hearing aid mode. In addition to hearing aid functionality for environmental listening, the Bose Hearing Aid can be used for placing and receiving telephone calls and for streaming audio from a Bluetooth compliant mobile device that has been paired with the Bose Hearing Aid. The controls accessible through the Bose Hear mobile application and on the hearing aid are used by the user to configure parameters, settings, and listening modes.
Here's a breakdown of the acceptance criteria and the study that proves the Bose Hearing Aid meets them, based on the provided text.
Acceptance Criteria and Device Performance
The Bose Hearing Aid underwent various tests to demonstrate its safety and effectiveness. These tests included electrical and battery safety, electromagnetic compatibility, mechanical performance, electroacoustic performance, usability engineering, and biocompatibility.
Here's a table summarizing the acceptance criteria and the reported device performance for several key areas:
| Test Category | Acceptance Criteria | Reported Device Performance | Study Proving Acceptance |
|---|---|---|---|
| Electrical & Wireless | Overvoltage Protection: |
- Draws 127 mA ± 20 mA (proper charging) within permissible operating voltage
- Continues charging down to 4.4V
- Continues charging up to at least 6.8V and no higher than 8.45V
- Draws no more than 2.5 mA beyond upper limit (protection circuitry function)
Wireless Technology: - Pairing, control, streaming verification with paired mobile device. | Overvoltage Protection: Pass
Wireless Technology: Pass | Non-clinical/Bench Studies - Electrical Testing (Table 2) |
| Mechanical | Neckband Fit: - Meet neckband opening and cord length design to accommodate the 5th to 95th percentile range of user anatomy (per 1988 Anthropometric Survey). | All requirements and expected measurements were within specified range. Accepted/Passed. | Non-clinical/Bench Studies - Mechanical Testing (Table 3) |
| Electroacoustic | Frequency Response Bandwidth: At least 250 Hz – 5 kHz
Maximum Acoustic Output: Less than or equal to 120 dB SPL
Output Distortion: Less than or equal to 5%
Input Distortion: Less than or equal to 5% (at 500 Hz, 100 dB SPL input, 80 dB SPL output)
EIN (Equivalent Input Noise): Less than or equal to 32 dB SPL
Latency: Less than or equal to 15 ms
Directionality: Room sound audible in both ears, scratching sound in left/right ear, silence in one ear with room sound in other, room sound only in one ear with no scratching. | All Pass | Non-clinical/Bench Studies - Electroacoustic Performance (Table 4) and Monaural/Binaural Directionality Verification (page 10). |
| Biocompatibility | Cytotoxicity (ISO 10993-5): No evidence of causing cell lysis or toxicity
Irritation (ISO 10993-10): Pass
Skin Sensitization (ISO 10993-10): No evidence of causing delayed dermal contact sensitization | Cytotoxicity: Pass (Grade 0)
Irritation: Pass (test score 0.0 and 0.1)
Skin Sensitization: Pass | Non-clinical/Bench Studies - Biocompatibility (Table 5) |
| Usability | Risks resulting from normal use and use errors are assessed and mitigated. Users can correctly use the device as intended under anticipated conditions of use. | Usability of the Bose hearing aid was analyzed, verified, and validated for its intended use, and implemented mitigations for user training and device labeling are adequate. User instructions and training materials were successful in allowing users to complete appropriate tasks. | Human Factors Study (described on page 18-19) |
| Effectiveness (Self-Fitting) | Primary Endpoint (Sound Quality): Prescribed parameters not significantly more preferred than DRC-selected ones.
Secondary Endpoints: - Speech-in-noise recognition performance (QuickSIN) of Self-Fit group significantly non-inferior to Pro-Fit group.
- Patient-reported outcomes (APHAB & SSQ-12) of Self-Fit group significantly non-inferior to Pro-Fit group.
- User-selected gain correlated with professionally-selected gain and comparable. | Primary Endpoint: Subjects in Self-Fit Group preferred their own settings more than professionally-selected settings (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.