(30 days)
The Bose SoundControl™ Hearing Aids 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. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).
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 Bose SoundControl Hearing Aids (Model BMD0012) are self-fitting wireless air conduction hearing aids consisting of the Novidan Inc. hardware, Bose software, the Bose Hear app, and accessories supplied in the carton.
Each hearing aid in the pair functions and interacts with the Bose Hear app independently and as a system. The hearing aids are powered by a disposable size 312 zinc-air battery. The hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with open or closed domes. The hearing aids are controlled via on-board button controls and wirelessly via the Bose Hear app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.
The provided text is a 510(k) Summary for the Bose SoundControl Hearing Aids (K211008). It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Bose Hearing Aid, DEN180026).
However, the document does not provide specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format of a clinical trial report with defined endpoints and statistical analysis. Instead, it argues for substantial equivalence primarily through comparison to a well-established predicate device and various non-clinical and human factors testing.
It states: "The range of testing and all acceptance criteria are appropriate to evaluate this device based on its proposed intended use. All acceptance criteria were met." but does not enumerate these criteria beyond the test names.
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Acceptance Criteria and Device Performance
The document doesn't explicitly state quantitative acceptance criteria for clinical performance of the Bose SoundControl Hearing Aids, but rather bases its claims on "substantial equivalence" to a predicate device and adequacy for fitting mild to moderate hearing loss. The "results" section primarily refers to "Pass" for various engineering and safety tests.
It also highlights the outcomes of a clinical study for the predicate device, stating it resulted in "outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss" and that "subjects in the Self-Fit Group were satisfied with and preferred their own self-adjusted settings to the professionally-selected settings." This is then extrapolated to the new device because the self-fitting method is the same.
A table summarizing the comparison to the predicate device's ANSI S3.22 data is provided, which serves as a form of acceptance criteria (i.e., being "Same" or "Adequate").
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Bose SoundControl Hearing Aids) | Discussion/Predicate Performance |
|---|---|---|---|
| Electrical Safety | Pass (per IEC 60601-1, IEC 60601-2-66, IEC 60601-1-11) | Pass | Satisfied requirements |
| Electromagnetic Compatibility (EMC) | Pass (per IEC 60601-1-2) | Pass | Satisfied requirements |
| Electroacoustic Performance | Pass (per ANSI/ASA S3.22 2014) | Pass | Satisfied requirements |
| Usability Engineering | Pass (per Bose-specified procedure, IEC 60601-1-6) | Pass | Safe and effective for intended users, uses, and environments |
| Biocompatibility | Pass (per ISO 10993-1, ISO 10993-5, ISO 10993-10) | Pass | Satisfied requirements |
| Software | Pass (per IEC 62304) | Pass | Satisfied requirements |
| Max OSPL90 | Equivalent to predicate (115 dBSPL), or adequate for fitting moderate hearing loss. | 113 dBSPL | "Same" as predicate (115 dBSPL) |
| HFA OSPL90 | Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2. | 106 dBSPL | Predicate: 112 dBSPL. Considered "Adequate" |
| HFA FOG | Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2. | 30 dB | Predicate: 43 dB. Considered "Adequate" |
| RTG | Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2. | 29 dB | Predicate: 36 dB. Considered "Adequate" |
| Frequency Response | Equivalent to predicate's range. | 8000 Hz) | |
| Harmonic Distortion | Equivalent to predicate's levels. |
§ 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.