BELTONE COMPOSER 2000 BTE HP
Device Facts
| Record ID | K955930 |
|---|---|
| Device Name | BELTONE COMPOSER 2000 BTE HP |
| Applicant | Beltone Electronics Corp. |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Mar 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
To amplify and transmit sound to the ear
Device Story
Air conduction hearing aid; amplifies and transmits sound to ear. Features dispenser programmability and user remote control. Assembled from standard industry components. Powered by standard hearing aid battery. Operated by patient; audiological characteristics dictated by individual audiogram. Controls include volume, switches, and dispenser-operated trimmers.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Air conduction BTE hearing aid; standard battery power; dispenser programmable; user remote control; volume/switch/trimmer controls. Technical specifications comply with ANSI S3.22-1987 standards.
Indications for Use
Indicated for individuals requiring sound amplification to compensate for hearing loss, as determined by an 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.
Predicate Devices
- Maico Gamma RD BTE HP (K933291)
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