Magnatone Hearing Aid Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Magnatone Hearing Aid Corp.” (first 1985, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 64 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 8 | 8 |
Review panels
Most recent Magnatone Hearing Aid Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973861 | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 | ESD | 1997-11-19 | 41 |
| K973665 | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER | ESD | 1997-11-04 | 40 |
| K944241 | MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID | ESD | 1994-11-16 | 77 |
| K911183 | NHS 2044P BODY AID, HEARING AID | ESD | 1991-07-09 | 113 |
| K911182 | NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS | ESD | 1991-05-09 | 52 |
| K911174 | NHS 2009SP HEARING AID | ESD | 1991-05-09 | 52 |
| K890525 | INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA | ESD | 1989-05-19 | 106 |
| K852656 | MODEL M HEARING AID | ESD | 1985-12-27 | 186 |
Recalls
openFDA lists no recalls under a recalling firm named Magnatone Hearing Aid Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Magnatone Hearing Aid Corp. Dba Persona Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Magnatone Hearing Aid Corp.?
FDA lists 8 510(k) clearances under the applicant name “Magnatone Hearing Aid Corp.” (first 1985, latest 1997), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Magnatone Hearing Aid Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Magnatone Hearing Aid Corp. is 64 days.
Which FDA product codes appear under Magnatone Hearing Aid Corp.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 8).
Next steps
- See all 8 Magnatone Hearing Aid Corp. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Magnatone Hearing Aid Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.