(74 days)
To amplifiy and transmit sound to the ear.
In The Ear Hearing Aid - Substantially equivalent to other In The Ear (ITE) hearing aids. Controls volume, gain, peak clipper, AGC, kneepoint low frequency out and high frequency out as appropriate. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications, Preliminary data sheets for the PHS models are enclosed. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.
The provided text describes a hearing aid device (COMFORTONE PHS HEARING AID) and its general characteristics. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and reported performance, nor can I answer questions 2 through 9 regarding study methodology, sample sizes, ground truth establishment, or expert involvement. The document is primarily a descriptive summary of the device for regulatory submission (K960741), not a study report.
§ 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.