(39 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
Configuration:
✓1. High Frequency - Precipitously Sloping
✓2. Gradually Sloping
✓3. Reverse Slope
✓4. Flat
Other
✓1. Low tolerance To Loudness
B. Specific Indications (Only if appropriate.):
(Most psychoacoustic indications such as improved speech
intellicibility in background noise, must be supported by clinical
data.)
Not Found
The provided text is a 510(k) clearance letter from the FDA for a hearing aid device (Widex Senso Digital Mini Canal). It does not contain information about acceptance criteria, study details, or performance data for the device.
The document primarily focuses on establishing "substantial equivalence" of the Widex Senso Digital Mini Canal to a predicate device already on the market, thereby allowing its marketing. It outlines the regulatory classification, general controls, and some potential future considerations (like electromagnetic interference).
Therefore, I cannot fulfill your request for the tables and study details based on the provided text, as this information is not present.
§ 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.