UNITRON MODEL SOUND F/X +4
Device Facts
| Record ID | K964503 |
|---|---|
| Device Name | UNITRON MODEL SOUND F/X +4 |
| Applicant | Unitron Industries, Inc. |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Nov 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
To amplify and transmit sound via air conduction to the ear.
Device Story
Behind-the-ear (BTE) hearing aid; amplifies/transmits sound via air conduction. Features two-channel compression circuitry; Class D circuitry for battery efficiency; telecoil with pre-amplifier. User-adjustable controls include cross-over frequency, low channel gain, and threshold knee point; volume control; microphone/telecoil/off switch. Powered by size 13 battery. Used by patients with hearing loss; adjustments performed by clinicians based on individual audiogram. Benefits include improved auditory perception through customized sound amplification.
Clinical Evidence
Bench testing only; compliance with ANSI S3.22-1987 standard.
Technological Characteristics
Behind-the-ear form factor; Class D circuitry; two-channel compression; telecoil with pre-amplifier; size 13 battery power. Technical specifications comply with ANSI S3.22-1987.
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.
