UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
Device Facts
| Record ID | K970519 |
|---|---|
| Device Name | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) |
| Applicant | Unitron Industries, Inc. |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Apr 24, 1997 |
| 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
In-the-ear programmable hearing aid; amplifies/transmits sound via air conduction. Features two-channel wide dynamic range compression (WDRC) circuitry; twin average compression detectors; Class D circuitry. Five programmable parameters: low-channel gain, high-channel gain, cross-over frequency, threshold kneepoint, power. Powered by standard hearing aid batteries (size 13, 312, or 10A). Operated by patient; adjustments performed by hearing healthcare professional. Output assists patient in hearing by compensating for hearing loss.
Clinical Evidence
Bench testing only; compliance with ANSI S3.22-1987 standard.
Technological Characteristics
In-the-ear form factor; Class D circuitry; two-channel WDRC; programmable parameters (gain, frequency, kneepoint). Power: size 13, 312, or 10A batteries. Compliance: ANSI S3.22-1987.
Indications for Use
Indicated for individuals requiring sound amplification via air conduction to the ear to compensate for hearing impairment.
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.
