(70 days)
Intended to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss.
Model WMR BTE is a dual-channel, wide-dynamic range input instrument which allows for loudness correction compression by changing compression ratios within the two bands. The WMR separates incoming signals into high and low frequency bands which can be independently compressed prior to recombination and amplification. The electronics for the hearing instrument are contained in a custom plastic case.
The Model WMR BTE features three adjustable trimmers that can only be adjusted by the dispenser to meet individual patient requirements. The user may adjust the gain (loudness) of the hearing instrument by rotating the volume control dial to his/her most comfortable listening level. This hearing instrument does not require a special fitting system; however, the trimmer controls may only be adjusted by an authorized hearing aid dispenser, NOT by the consumer. Notes to this effect are included in the User Instruction Booklet included in this submission.
- The crossover frequency between the low band and high band channels; 1)
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- High band compression ratio;
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- Low band compression ratio
This 510(k) summary describes a hearing aid, which is a medical device that predates the widespread use of software-driven AI or complex algorithms as we understand them today in healthcare. Therefore, the information requested in your prompt (especially concerning AI/ML performance, ground truth, expert adjudication, MRMC studies, and training/test sets) is largely not applicable to this document.
However, I can extract the information that is present regarding performance and criteria for this type of device.
1. A table of acceptance criteria and the reported device performance
For a hearing aid submitted in 1996, "acceptance criteria" and "reported device performance" are primarily tied to compliance with established industry standards rather than a quantitative accuracy metric common for modern AI devices.
| Acceptance Criteria (Compliance Standard) | Reported Device Performance (Compliance Statement) |
|---|---|
| ANSI S3.22-1987 (Revision of S3.22-1982) - Specification of Hearing Aid Characteristics | "Performance data for this submission has been obtained in accordance with the test procedures of the American National Standard Specification of Hearing Aid Characteristics, ANSI S3.22-1987 (Revision of S3.22-1982)." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a hardware product. The "test set" would be the device itself tested against an industry standard. There's no "data provenance" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of this device refers to the physical and acoustical properties as defined by the ANSI standard. This is established by engineering and acoustical measurement, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no "adjudication" of results in the sense of multiple human reviewers. Performance is based on objective, quantifiable physical measurements against a standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a standalone hearing aid, not an AI-assisted diagnostic or interpretive tool that would be used by "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a way. The device itself (the "algorithm" in a loose interpretation of its function) is tested standalone against the ANSI standard. Its performance is measured directly without human interaction beyond operating the test equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by the American National Standard Specification of Hearing Aid Characteristics, ANSI S3.22-1987. This standard sets objective, measurable criteria for hearing aid performance, such as frequency response, maximum output, and distortion.
8. The sample size for the training set
Not applicable. This is a hardware device. There is no "training set" in the machine learning sense. The device is designed and engineered.
9. How the ground truth for the training set was established
Not applicable. No training set in the AI sense. The design of the device is based on established principles of acoustics and audiology, aiming to meet the performance criteria outlined in the ANSI standard for addressing hearing loss.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.