← Product Code [KHL](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL) · K790481

# MODEL FS1 (K790481)

_Starkey Laboratories, Inc. · KHL · Apr 3, 1979 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K790481

## Device Facts

- **Applicant:** Starkey Laboratories, Inc.
- **Product Code:** [KHL](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL.md)
- **Decision Date:** Apr 3, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3330
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K790481](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K790481)

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