← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K961653

# PHONAK SONA P2 (K961653)

_Phonak, Inc. · ESD · May 29, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961653

## Device Facts

- **Applicant:** Phonak, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** May 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Intended Use

To amplify and transmit sound to the ear

## Device Story

Phonak Sona P2; programmable in-the-canal hearing instrument. Input: ambient sound. Processing: frequency response, gain, and output limiting adjusted to individual audiogram; 3 programmable memories; 5 output limiting forms. Output: amplified sound. Operation: remote control; battery-powered (size 312 or 10). Use: clinic/dispenser setting; patient self-use. Benefit: improved auditory perception for hearing-impaired users.

## Clinical Evidence

Bench testing only; technical specifications comply with ASA/ANSI S3.2-1987.

## Technological Characteristics

Programmable in-the-canal hearing instrument; 3 memories; 5 output limiting modes; remote control interface; battery-powered (size 312 or 10); technical specifications comply with ASA/ANSI S3.2-1987.

## 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.

## Submission Summary (Full Text)

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K961653

# Exhibit 8

## Summary of Safety and Effectiveness Information

Name of device : Phonak Sona P2

Type of device : Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments

Intended Use : To amplify and transmit sound to the ear

Features : 3 programmable memories, 5 forms of output limiting, remote control

Assembly : Assembled from components available to hearing instrument manufacturer. Delivered completely assembled to the dispenser

Tech. Characteristics : Technical specifications comply with ASA/ANSI S3.2 - 1987

Fit : Frequency response, gain, output are fit to the individual audiogram

Controls : Operated with remote control

Power Source : Standard hearing instrument battery, size 312 or 10

A user’s manual and other information is supplied with each hearing instrument.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961653](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961653)

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