Who is the manufacturer of DIGIFOCUS ITE?

Oticon, Inc. submitted the Traditional clearance for DIGIFOCUS ITE (K964683).

What is the FDA product code for DIGIFOCUS ITE?

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 DIGIFOCUS ITE?

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

DIGIFOCUS ITE

K964683 · Oticon, Inc. · ESD · Dec 12, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K964683
Device Name	DIGIFOCUS ITE
Applicant	Oticon, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Dec 12, 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 ITE (DFI) is an in-the-ear hearing aid; utilizes true digital signal processing (DSP) for sound amplification. Input: acoustic signals. Processing: seven-band frequency shaping; two-channel compression system (syllabic compression <1500 Hz; nonsyllabic compression >1500 Hz). Output: amplified sound delivered to ear. Operation: digitally programmed via OtiSet software on NOAH platform; powered by size 312 battery. Used by patients with hearing impairment; fitted by audiologists/hearing professionals based on audiometric data. Benefits: improved sound audibility and speech understanding.

Clinical Evidence

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

Technological Characteristics

Seven-band, two-channel digital signal processing (DSP) hearing instrument. Components: custom microchips on flexfilm. Power: size 312 battery. Technical specs: ANSI S3.22-1987. Fitting: digitally programmed via OtiSet software.

Indications for Use

Indicated for individuals requiring sound amplification to address hearing loss, with fitting parameters determined by individual audiometric and patient history data.

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

K961059 — DIGIFOCUS COMPACT · Oticon, Inc. · May 7, 1996
K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL · Sonic Innovations, Inc. · Mar 12, 1999
K963915 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION · Telex Communications, Inc. · Nov 8, 1996
K972755 — V-12 LONG LIFE 675 HEARING AID · Vista Labs · Aug 5, 1997
K964639 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II · Telex Communications, Inc. · Jan 21, 1997

Submission Summary (Full Text)

{0} K964683 DEC 12 1996 oticon OTICON, INC. 29 Schoolhouse Road P.O. Box 6724 Somerset, NJ 08875-6724 Toll-Free 1-800-526-3921 FAX (908) 560-0029 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 ITE (DFI) **TYPE OF DEVICE:** In 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 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 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 OtiSet software using the standard NOAH platform. The hearing aid may have an optional T-M switch. **POWER SOURCE:** Standard size 312 battery. A USER INSTRUCTIONAL BROCHURE, INCLUDING ANSI TECHNICAL DATA IS SUPPLIED WITH EACH HEARING AID.