Finetone Hearing Instruments: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Finetone Hearing Instruments” (first 1983, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 97 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 | 4 | 4 |
| LRB | Face Plate Hearing Aid | 1 | 1 |
Review panels
Most recent Finetone Hearing Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974219 | FACEPLATE ASSEMBLY | LRB | 1998-02-20 | 102 |
| K955692 | FINETONE FSC, | ESD | 1996-02-02 | 50 |
| K945780 | FINETONE DISCEET CANAL | ESD | 1994-12-21 | 26 |
| K940164 | SUPER-SIL | ESD | 1994-06-29 | 174 |
| K830960 | CUSTOM IN-THE-EAR HEARING AID | ESD | 1983-06-30 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Finetone Hearing Instruments.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Finetone Hearing Instruments?
FDA lists 5 510(k) clearances under the applicant name “Finetone Hearing Instruments” (first 1983, latest 1998), across 2 product codes 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 Finetone Hearing Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Finetone Hearing Instruments is 97 days.
Which FDA product codes appear under Finetone Hearing Instruments?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 4); LRB (Face Plate Hearing Aid, 1).
Next steps
- See all 5 Finetone Hearing Instruments clearances with predicates and recalls
- Run predicate analysis for product code ESD, Finetone Hearing Instruments'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.