(29 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: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.
Meridian DSP (Hearing Aid)
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a hearing aid (Meridian DSP) in 1997. It primarily focuses on:
- Substantial Equivalence: Confirming the device is substantially equivalent to legally marketed predicate devices.
- Regulatory Classification: Stating the device's regulatory class (Class I) and applicable regulations.
- General Controls: Mentioning requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
- Electromagnetic Interference (EMI): Advising the manufacturer about potential EMI from digital cellular telephones and suggesting labeling modifications.
- Indications for Use: Detailing the types and severities of hearing loss the device is intended for.
The document does not include any performance metrics, study design, sample sizes, ground truth establishment, or expert involvement related to the device's efficacy or performance characteristics. It's a regulatory clearance document, not a scientific 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.