← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964035

# PHONAK MICROLINK, PERSONAL FM RECEIVER (K964035)

_Phonak, Inc. · ESD · Dec 4, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964035

## Device Facts

- **Applicant:** Phonak, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Dec 4, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Indications for Use

To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct input from the person lecturing.

## Device Story

Personal FM receiver; connects to Phonak BTE hearing instruments via audio input; receives FM signals from same-channel transmitter/microphone; feeds audio directly to hearing aid; powered by hearing aid battery; features FM-only or FM/M input selection switch; used in settings like lecture halls to improve speech intelligibility; operated by hearing aid user; delivered pre-assembled to dispensers or schools.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Personal FM receiver; 216 MHz frequency band; complies with FCC Part 90 rules; powered by hearing aid battery; audio input connection to BTE hearing instruments; manual input selection switch.

## 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.

## Submission Summary (Full Text)

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PTCNAK The Choice of Professionals
K964035
DEC - 4 1996

# Exhibit 4
## A Summary of Safety and Effectiveness Information

**Name of Device:** Phonak MicroLINK FM Receiver

**Type of Device:** Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.

**Intended use:** To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct input from the person lecturing.

**Features/Controls:** Switch for FM alone or FM/M input selection.

**Assembly:** Assembled from components available to hearing aid manufacturers. Delivered completely assembled to the dispenser or school.

**Technical Characteristics:** Technical specifications comply with part 90 FCC rules. Frequencies used are in the 216 MHz band.

**Power source:** Unit draws power from hearing aid battery.

A user’s manual and other information is supplied with each instrument to the consumer.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964035](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964035)

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