UNITRON MODEL ICON KR
Device Facts
| Record ID | K963122 |
|---|---|
| Device Name | UNITRON MODEL ICON KR |
| Applicant | Unitron Industries, Inc. |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Sep 6, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
To amplify and transmit sound via air conduction to the ear.
Device Story
Behind-the-ear hearing aid; amplifies and transmits sound via air conduction. Features K-Amp circuit with Wide Dynamic Range compression; Class D circuits for battery efficiency; telecoil with pre-amplifier. User-adjustable controls include Low Cut Tone, High Cut Tone, Threshold Knee-point, and volume. Powered by size 13 battery. Operated by patient; adjustment dictated by individual audiogram. Benefits include improved sound perception for hearing-impaired users.
Clinical Evidence
Bench testing only; technical specifications comply with ANSI Standard S 3.22-1987.
Technological Characteristics
Behind-the-ear form factor; K-Amp circuit with Wide Dynamic Range compression; Class D output stage; telecoil with pre-amplifier; size 13 battery power; ANSI S 3.22-1987 compliant.
Indications for Use
Indicated for individuals requiring sound amplification via air conduction to the ear, adjusted 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
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- K964503 — UNITRON MODEL SOUND F/X +4 · Unitron Industries, Inc. · Nov 27, 1996
- K964504 — UNITRON MODEL ICON AOHPL +4 · Unitron Industries, Inc. · Nov 27, 1996
- K960155 — UNITRON MODEL SOUND F/XP · Unitron Industries, Inc. · Mar 7, 1996
