PHONAK MICROLINK, PERSONAL FM RECEIVER

K964035 · Phonak, Inc. · ESD · Dec 4, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964035
• Device Name: PHONAK MICROLINK, PERSONAL FM RECEIVER
• Applicant: Phonak, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Dec 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1

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.

Indications for Use

Indicated for individuals using Phonak BTE hearing instruments requiring direct FM audio input for improved signal reception in environments like lecture halls.

Regulatory Classification

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.