(40 days)
To amplify and transmit sound to the ear.
BTE Hearing Aid
This document describes an Audiotone A-554 BTE hearing aid, which is a Class I medical device. However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
Therefore, I cannot fulfill your request for the detailed table and study information. The input focuses on the device's classification, intended use, technical characteristics (ANSI S3.22-1987 methodology for testing), and general specifications, but lacks the specific performance data and study details you've asked for.
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Appendix B
JAN 2 7 1997
Summary of Safety and Effectiveness
| Device Name: | Audiotone A-554 BTE |
|---|---|
| Device Type: | BTE Hearing Aid |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I |
| Intended Use: | To amplify and transmit sound to the ear. |
| Substantially Equivalent to: | Audiotone model A-54 which was cleared for distribution under document control number K941121. |
| Registration Number: | 2110592 |
| Materials: | The hearing aid cases will be manufactured from materials that are commonly used in the industry. |
| Technical Characteristics: | Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids. |
| Fit: | Mild to severe as dictated by the individual users audiogram. |
| Power: | Zinc-Air size 13 battery |
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§ 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.