Audina Hearing Instrument, Inc
Longwood, FL, US
AUDINA HEARING INSTRUMENT, INC appears in FDA device records in Longwood, FL. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Audina Hearing Instrument, Inc between 1982 and 1997. The busiest year on record is 1990, with 2. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1990 | 2 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964816 | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR | ESD | Substantially Equivalent | |
| K953960 | HEARING AID (ALL-IN-THE-EAR) | ESD | Substantially Equivalent | |
| K942236 | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | LRB | Substantially Equivalent | |
| K936190 | BEHIND THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K930271 | BEHIND-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K897024 | MODEL AUDINA ITE HEATING AID | ESD | Substantially Equivalent | |
| K897023 | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | LRB | Substantially Equivalent | |
| K820833 | AUDICRAFT VIP HEARING AID | ESD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1052698 | 1000113652 | AUDINA HEARING INSTRUMENT, INC | 165 E Wildmere Ave, LONGWOOD, FL 32750 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Audina Hearing Instrument, Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain