(41 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).
Magna-PWR, Magna-B, Integra 70-74, Futura 67M-68M, MP97, Supra 51-52, Supra 56-59 and Suprema 45-48 Hearing Aids
I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) premarket notification approval letter for various hearing aid models from 1997. It confirms substantial equivalence to previously marketed devices and outlines general regulatory compliance and concerns about electromagnetic interference.
Specifically, the text does not include:
- Acceptance criteria tables for device performance.
- Details of any specific studies (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies).
- Information on how ground truth was established for any training or test sets.
The included "Indications For Use" pages describe the types and severity of hearing loss these hearing aids are intended to address, but this is not a performance study or a set of acceptance criteria.
§ 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.