Who is the manufacturer of LONG LIFE RX-12?

Rexton, Inc. filed the 510(k) submission for LONG LIFE RX-12 (K960295).

What is the FDA product code for LONG LIFE RX-12?

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 LONG LIFE RX-12?

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

Who can help prepare an FDA 510(k) submission like LONG LIFE RX-12?

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.

LONG LIFE RX-12

K960295 · Rexton, Inc. · ESD · Mar 22, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K960295
Device Name	LONG LIFE RX-12
Applicant	Rexton, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Mar 22, 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

In-the-ear (ITE) hearing aid; utilizes 675 battery and low-drain class D circuit for extended battery life; assembled from standard industry components. Device amplifies and transmits sound to ear; frequency response tailored to patient audiogram. Used by patients with hearing loss; operated by user. Benefits include ease of battery handling and increased operational duration.

Clinical Evidence

Bench testing only; technical specifications obtained in accordance with ANSI S3.22-1987.

Technological Characteristics

ITE form factor; low-drain class D circuit; 675 battery power source; frequency response customized per audiogram; technical specifications compliant with ANSI S3.22-1987.

Indications for Use

Indicated for individuals with hearing loss requiring sound amplification; frequency response customized based on 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

K972755 — V-12 LONG LIFE 675 HEARING AID · Vista Labs · Aug 5, 1997
K971845 — HEARTLAND TECHNOLOGIES, ITE, ITC, CIC · Sound Hearing Instruments, Inc. · Aug 15, 1997
K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) · Unitron Industries, Inc. · Nov 27, 1996
K964504 — UNITRON MODEL ICON AOHPL +4 · Unitron Industries, Inc. · Nov 27, 1996
K964639 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II · Telex Communications, Inc. · Jan 21, 1997

Submission Summary (Full Text)

{0} K960295 # A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION **Name of Device:** Rexton's Long Life Rx-12 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:** The Rexton Long Life Rx-12 is a full shell hearing aid utilizing a 675 battery and a low drain class D circuit. The combination of these to unique features gives the Rexton Long Life the ease of battery handling (a large 675 battery) and the benefits of extended battery life. These two features should make for a special product with-in the industry. **Assembly:** Assembled from standard components which are widely utilized by other hearing aid manufacturers. **Technical Characteristics:** Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the Rexton Long Life RX-12 models are enclosed. **Fit:** The frequency response of this product is dictated by the individual audiogram from each client. **Power:** Standard hearing aid battery, 675. A user’s manual and other information is supplied with each hearing aid. Rexton, inc. 510(k) submission; page 2