Resound Corp.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Resound Corp.” (first 1989, latest 1999), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 50 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 | 33 | 33 |
| EWO | Audiometer | 3 | 3 |
| ELW | Material, Impression | 1 | 1 |
| EPF | Hearing Aid, Group And Auditory Trainer | 1 | 1 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
| KHL | Hearing Aid, Master | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
Review panels
Most recent Resound Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984547 | DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS | EWO | 1999-03-19 | 87 |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | ESD | 1997-12-12 | 29 |
| K974081 | RESOUND STEALTH CIC | ESD | 1997-12-12 | 44 |
| K971605 | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | ESD | 1997-07-03 | 63 |
| K970215 | AUDALLION II HEARING SYSTEM | ESD | 1997-03-31 | 69 |
| K964557 | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | ESD | 1996-11-27 | 14 |
| K964115 | RESOUND CC4 PERSONAL HEARING SYSTEM | ESD | 1996-11-04 | 20 |
| K960684 | HEARING AID - AIR CONDUCTION | ESD | 1996-04-10 | 50 |
| K960680 | RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 | ESD | 1996-04-10 | 50 |
| K960052 | RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 | ESD | 1996-03-12 | 68 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Resound 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Resound Corp.?
FDA lists 41 510(k) clearances under the applicant name “Resound Corp.” (first 1989, latest 1999), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Resound Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Resound Corp. is 50 days.
Which FDA product codes appear under Resound Corp.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 33); EWO (Audiometer, 3); ELW (Material, Impression, 1).
Next steps
- See all 41 Resound Corp. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Resound 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.