(73 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Other Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other 1. Low tolerance To Loudness
BETTER HEARING, INC. model C-1 Hearing Aid, Type: Behind-The-Ear (BTE), Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery
This document is a 510(k) summary for the BETTER HEARING, INC. Model C-1 Hearing Aid. It confirms substantial equivalence to other devices rather than presenting a study to prove meeting acceptance criteria in the way a clinical trial for a novel device would. Therefore, most of the requested fields are not applicable (N/A) as this is a premarket notification for a Class I device and not a clinical study report.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially Equivalent to Predicate Device | Confirmed as "substantially equivalent" to “other medium power compression BTE hearing aids”. |
| Meets ANSI S3.22 1987 Standard | "Hearing Aid has been tested per ANSI S3.22 1987." |
| Fits Mild to Moderate Hearing Losses | "Fits: Mild to moderate hearing losses." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: N/A (No specific test set or clinical study described in detail for performance evaluation beyond compliance with a standard.)
- Data Provenance: N/A (The document focuses on regulatory compliance and substantial equivalence, not a clinical study with geographic or temporal data origin.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A (No ground truth established by experts for a test set is discussed in this regulatory summary.)
4. Adjudication method for the test set
- N/A (No test set or adjudication method is described.)
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
- N/A (This device is a hearing aid, not an AI-powered diagnostic device. No MRMC study was performed.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (Not an AI algorithm.)
7. The type of ground truth used
- N/A (The "ground truth" here is the regulatory standard of substantial equivalence and compliance with ANSI S3.22 1987, rather than a clinical ground truth for a diagnostic task.)
8. The sample size for the training set
- N/A (Not an AI device; no training set in the AI sense.)
9. How the ground truth for the training set was established
- N/A (Not an AI device; no training set in the AI sense.)
§ 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.