(24 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: ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency -Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat
Sound F/XP Programmble Mini BTE Hearing Aid
The provided text is a 510(k) premarket notification letter from the FDA regarding a hearing aid device (Unitron Industries, Inc. Sound F/XP Programmable Mini BTE Hearing Aid).
This document does not contain information related to acceptance criteria or a study proving device performance against acceptance criteria.
The letter is primarily a regulatory approval document stating that the device is "substantially equivalent" to legally marketed predicate devices for specific indications of use. It outlines general compliance requirements, potential future concerns regarding electromagnetic interference, and contact information for regulatory advice.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.