← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K961827

# IN-THE-EAR (K961827)

_Qualitone · ESD · Jul 3, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961827

## Device Facts

- **Applicant:** Qualitone
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Jul 3, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Device Story

DSD K-AMP Option; hearing aid instrument. Input: ambient sound. Processing: traditional sound amplification/processing principles. Output: amplified sound for user. Used in clinical or daily settings by hearing-impaired patients. Device provides auditory assistance; improves sound perception for users.

## Clinical Evidence

Bench testing only; performance meets ANSI S-3.22 1987 requirements.

## Technological Characteristics

Hearing aid instrument; traditional sound processing; performance compliant with ANSI S-3.22 1987.

## Regulatory 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.

## Reference Devices

- Qualitone hearing aid devices

## Submission Summary (Full Text)

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K961827

JUL - 3 1996

Summary of Safety And Effectiveness
for DSD K-AMP Option

The summary of information, new product to present products demonstrates substantial equivalence as required by the "Safe Medical Devices Act (SMDA)" of 1990. The design follows traditional principles of operation for hearing aid instruments. This device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S-3.22 1987. User controls and methods are similar to other products currently on the market. Sound processing for this instrument is also similar to devices presently marketed by Qualitone.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961827](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961827)

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