# K962228: Model Alpha Behind-the-Ear Hearing Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Ototech Intl., Inc.
- Decided: Aug 28, 1996 after 79 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Starkey SM PC: named in the summary without a submission number
- (no number) Starkey SM Vega: named in the summary without a submission number
- (no number) Bosch Star 22: named in the summary without a submission number

## Indications for use
The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss.

Source page: https://510kreport.com/device/K962228
Methodology: https://510kreport.com/methodology