TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION

K963915 · Telex Communications, Inc. · ESD · Nov 8, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963915
• Device Name: TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
• Applicant: Telex Communications, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 8, 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) custom hearing aid; amplifies and transmits sound to ear. Input: ambient sound via microphone. Processing: amplifier with optional dynamic range compression (threshold compression) to adjust output levels. Output: amplified sound delivered to ear canal. Used in clinical or daily settings by patients with hearing loss. Healthcare provider adjusts settings via volume control, low/high cut trimmers, and threshold control. Benefits: improved auditory perception and communication for hearing-impaired users.

Clinical Evidence

Bench testing only; compliance with ANSI S3.2-1987 standards for frequency response and technical specifications.

Technological Characteristics

ITE form factor; standard hearing aid battery power (13, 312, 10A, or 5A); analog amplifier with dynamic range compression; manual controls (volume, trimmers, switches); complies with ANSI S3.2-1987.

Indications for Use

Indicated for individuals requiring sound amplification to compensate for hearing loss.

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.

Predicate Devices

• Telex Model 28A (K922066)

Submission Summary (Full Text)

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TELEX
Telex Communications, Inc.

Item C

NOV - 8 1996
K963915

9600 Aldrich Avenue South
Minneapolis, Minnesota 55420 USA
Telephone [phone]
Fax [phone]

510(K) SUMMARY

Trade Name: Telex In-the-Ear Custom Hearing Aid Compression®
Common Name: Hearing Aid, ITE
Classification Name: Air Conduction Hearing Aid, 77ESD
Equivalent to: Telex Model 28A K922066

Description:
Intended use: to amplify and transmit sound to the ear.
Features: Threshold Compression
Assembly: assembled from standard components that are widely used by other hearing aid manufacturers.
Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards.
Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k).
Controls: Volume control, Low cut Trimmer (optional), High cut Trimmer (optional), Threshold Control, Loudness Boost (optional), Set-screw Volume Control (optional), Low cut Switch (optional)
Power: Standard hearing aid battery (13, 312, 10A or 5A)

Comparison to predicate device: identical to the model 28A, except for different amplifier which incorporates dynamic range compression as an optional compensation strategy.

Submitted by:
Tom Scheller
Chief Engineer
Hearing Instruments Group
Telex Communications, Inc.
9600 Aldrich Ave S.
Minneapolis, MN 55420
[phone] voice
[phone] fax

Contact: Tom Scheller
Prepared: September 16, 1996