Who is the manufacturer of COMFORTONE PHS?

Comfortone America'S Value Hearing Aid Line filed the 510(k) submission for COMFORTONE PHS (K960741).

What is the FDA product code for COMFORTONE PHS?

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 COMFORTONE PHS?

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

Who can help prepare an FDA 510(k) submission like COMFORTONE PHS?

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.

COMFORTONE PHS

K960741 · Comfortone America'S Value Hearing Aid Line · ESD · May 7, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K960741
Device Name	COMFORTONE PHS
Applicant	Comfortone America'S Value Hearing Aid Line
Product Code	ESD · Ear, Nose, Throat
Decision Date	May 7, 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

ComfortOne PHS Hearing Aid; in-the-ear (ITE) device; amplifies and transmits sound to ear. Operates via standard hearing aid components; features include volume control, gain, peak clipper, AGC, and frequency output adjustments. Frequency response customized based on individual client audiogram. Powered by standard hearing aid battery. Used by patients with hearing impairment; fitted by hearing healthcare professionals based on audiometric data to improve auditory perception.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

In-the-ear (ITE) form factor; standard hearing aid components; battery-powered; frequency response adjustable per audiogram; controls include volume, gain, peak clipper, AGC, and frequency output. Complies with ANSI S3.22-1987 specifications.

Indications for Use

Indicated for individuals requiring sound amplification to address hearing loss, as determined by an individual audiogram.

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

K964639 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II · Telex Communications, Inc. · Jan 21, 1997
K971845 — HEARTLAND TECHNOLOGIES, ITE, ITC, CIC · Sound Hearing Instruments, Inc. · Aug 15, 1997
K972097 — PHONAK MICROZOOM P 2 · Phonak, Inc. · Jul 30, 1997
K972755 — V-12 LONG LIFE 675 HEARING AID · Vista Labs · Aug 5, 1997
K970519 — UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) · Unitron Industries, Inc. · Apr 24, 1997

Submission Summary (Full Text)

{0} K960741 MAY - 7 1996 # A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION | NAME OF DEVICE: | COMFORTONE PHS HEARING AID | | --- | --- | | TYPE OF DEVICE: | In The Ear Hearing Aid - Substantially equivalent to other In The Ear (ITE) hearing aids. | | INTENDED USE: | To amplify and transmit sound to the ear. | | FEATURES: | Controls volume, gain, peak clipper, AGC, kneepoint low frequency out and high frequency out as appropriate. | | ASSEMBLY: | Assembled from standard components which are widely utilized by other hearing aid manufacturers. | | TECHNICAL CHARACTERISTICS: | Technical specifications comply with S3.22-1987 ANSI Specifications, Preliminary data sheets for the PHS models are enclosed. | | FIT: | The frequency response of this product is dictated by the individual audiogram from each client. | | POWER: | Standard hearing aid battery. | A users manual and other information is supplied with each hearing aid (enclosed).