Who is the manufacturer of PHONAK PICONET2 P2 AZ?

Phonak, Inc. filed the 510(k) submission for PHONAK PICONET2 P2 AZ (K961622).

What is the FDA product code for PHONAK PICONET2 P2 AZ?

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 PICONET2 P2 AZ?

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

Who can help prepare an FDA 510(k) submission like PHONAK PICONET2 P2 AZ?

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 PICONET2 P2 AZ

K961622 · Phonak, Inc. · ESD · May 17, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K961622
Device Name	PHONAK PICONET2 P2 AZ
Applicant	Phonak, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	May 17, 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

Programmable behind-the-ear hearing instrument; amplifies and transmits sound to ear. Features 3 programmable memories, telecoil, 5 output limiting forms, and remote control. Operated by user via manual volume control/on-off switch or remote control. Powered by size 13 hearing instrument battery. Delivered fully assembled to dispenser; frequency response, gain, and output adjusted to individual audiogram.

Clinical Evidence

No clinical data; device performance based on technical specifications and compliance with industry standards.

Technological Characteristics

Programmable behind-the-ear hearing instrument; ASA/ANSI S3.2-1987 compliant. Features: 3 programmable memories, telecoil, 5 output limiting modes, remote control. Power: size 13 battery. Manual volume/power control.

Indications for Use

Indicated for individuals requiring sound amplification to address hearing loss, fit to individual audiogram requirements.

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

K972106 — PHONAK NOVO FORTE E3 · Phonak, Inc. · Aug 15, 1997
K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION · Resound Corp. · Nov 27, 1996
K972097 — PHONAK MICROZOOM P 2 · Phonak, Inc. · Jul 30, 1997
K963122 — UNITRON MODEL ICON KR · Unitron Industries, Inc. · Sep 6, 1996
K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) · Unitron Industries, Inc. · Nov 27, 1996

Submission Summary (Full Text)

{0} K961422 Exhibit 8 MAY 17 1996 # Summary of Safety and Effectiveness Information Name of device : Phonak Piconet2 P2 AZ Type of device : Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments Intended Use : To amplify and transmit sound to the ear Features : 3 programmable memories, telecoil, 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 : Both manually operated volume control with on/off and/or remote control is available Power Source : Standard hearing instrument battery, size 13 A user’s manual and other information is supplied with each hearing instrument.