(14 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: Moderate
Configuration: 1- TWIST PP AGC-1 1. High Frequency - Precipitously Sloping; TWIST PR. Flat
Other: TWIST PP AGC-1 1. Low tolerance To Loudness
Not Found
I am sorry, but the provided text does not contain the information needed to fill out the table and answer the questions about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for two hearing aid devices (TWIST PP and TWIST PP AGC-1) from 1997. It primarily discusses regulatory classification, substantial equivalence, and general controls, along with a brief section on electromagnetic interference and labeling.
It does not include:
- Specific acceptance criteria for device performance (e.g., in terms of sensitivity, specificity, accuracy).
- Details of any study conducted to prove the device meets acceptance criteria.
- Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document states that the devices are for "amplifying sound for individuals with impaired hearing" and specifies general indications related to severity (moderate) and configuration (high frequency - precipitously sloping for TWIST PP AGC-1, and flat for TWIST PP) of hearing loss, as well as low tolerance to loudness for TWIST PP AGC-1. However, these are indications for use, not performance acceptance criteria or study results.
§ 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.