Who is the manufacturer of PHONAK SONA P2?

Phonak, Inc. filed the 510(k) submission for PHONAK SONA P2 (K961653).

What is the FDA product code for PHONAK SONA P2?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for PHONAK SONA P2?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PHONAK SONA P2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PHONAK SONA P2

K961653 · Phonak, Inc. · ESD · May 29, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K961653
Device Name	PHONAK SONA P2
Applicant	Phonak, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	May 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3300
Device Class	Class 1
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.

Indications for Use

Indicated for individuals with hearing loss requiring sound amplification and transmission to the ear.

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.

Related Devices

K972097 — PHONAK MICROZOOM P 2 · Phonak, Inc. · Jul 30, 1997
K972105 — PHONAK EPICA · Phonak, Inc. · Aug 1, 1997
K972106 — PHONAK NOVO FORTE E3 · Phonak, Inc. · Aug 15, 1997
K961622 — PHONAK PICONET2 P2 AZ · Phonak, Inc. · May 17, 1996
K960741 — COMFORTONE PHS · Comfortone America'S Value Hearing Aid Line · May 7, 1996

Submission Summary (Full Text)

{0} 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. 37