(21 days)
A. General Indications: 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: 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope 4. Flat ✓ 5. Other Other 1. Low tolerance To Loudness ✓ 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise. must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.
Not Found
I am sorry, but I cannot answer your request as the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA letter regarding the substantial equivalence of a hearing aid (Oticon DigiSound ITE Hearing Aid) to previously marketed devices. It primarily discusses regulatory classifications, general controls, and potential issues like electromagnetic interference, and provides indications for use for the device.
§ 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.