DIGIFOCUS COMPACT

K961059 · Oticon, Inc. · ESD · May 7, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K961059
• Device Name: DIGIFOCUS COMPACT
• Applicant: Oticon, Inc.
• 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 deliver sound to the ear

Device Story

DigiFocus Compact (DFC) is a behind-the-ear hearing aid; utilizes digital signal processing (DSP) to amplify and deliver sound. Device features seven-band frequency shaping and two-channel compression system: syllabic compression for frequencies below 1500Hz; nonsyllabic compression for frequencies above 1500Hz. Operated by patient; parameters digitally programmed via software by clinician based on audiometric data. Includes manual OTM switch. Powered by standard type 13 battery. Benefits patient by providing customized sound amplification to compensate for hearing impairment.

Clinical Evidence

No clinical data; bench testing only per ANSI S3.22-1987.

Technological Characteristics

Behind-the-ear hearing aid; seven-band, two-channel digital signal processing (DSP). Components mounted on flexfilm with custom microchips. Powered by type 13 battery. Technical specifications comply with ANSI S3.22-1987. Features manual OTM switch and software-based digital programming.

Indications for Use

Indicated for individuals requiring sound amplification to address hearing loss, with specific frequency response, compression, gain, and SSPL 90 parameters determined by individual audiometric data and patient history.

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.

Submission Summary (Full Text)

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K961059/A1

MAY - 7 1996

oticon

8 Apr 95 1:31

OTICON, INC.

29 Schoolhouse Road

P.O. Box 6724

Somerset, NJ 08875-6724

Toll-Free 1-800-526-3921

FAX [phone]

This 510(k) summary safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

NAME OF DEVICE: DigiFocus Compact (DFC)

TYPE OF DEVICE: Behind The Ear Hearing Aid

INTENDED USE: To amplify and deliver sound to the ear

FEATURES: DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 54 dB HFA gain.

ASSEMBLY: Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm.

TECHNICAL CHARACTERISTICS: Technical specifications are in accordance with ANSI Standards S3.22-1987.

FITTING CRITERIA: Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data.

ADJUSTMENTS/ CONTROLS: All parameters are digitally programmed via software. The hearing aid has a manual OTM switch.

POWER SOURCE: Standard type 13 battery.

A USER INSTRUCTIONAL BROCHURE, INCLUDING ANSI TECHNICAL DATA IS SUPPLIED WITH EACH HEARING AID