(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.
§ 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.