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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.

Let's break down what information is available and what is missing based on your request.

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

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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:

• 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

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