Starkey Laboratories, Inc.: FDA filings under this applicant name
FDA lists 61 510(k) clearances under 2 spellings of the applicant name “Starkey Laboratories, Inc.” (first 1977, latest 2020), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 | 1 | 42 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 28 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Starkey Laboratories, Inc. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 39 | 39 |
| KLW | Masker, Tinnitus | 10 | 10 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 4 | 4 |
| EWO | Audiometer | 3 | 3 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| ERA | Otoscope | 1 | 1 |
| KHL | Hearing Aid, Master | 1 | 1 |
| LRB | Face Plate Hearing Aid | 1 | 1 |
| LXB | Hearing Aid, Bone Conduction | 1 | 1 |
Review panels
- Ear, Nose and Throat (60)
- Anesthesiology (1)
Most recent Starkey Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201370 | Multiflex Tinnitus Technology | KLW | 2020-06-19 | 28 |
| K122876 | MULTIFLEX TINNITUS TECHNOLOGY | KLW | 2012-10-31 | 42 |
| K030180 | CRESCENT TINNITUS RETAINING SOUND GENERATOR | KLW | 2003-09-17 | 243 |
| K970952 | PRECISE IMPRESSION KIT | ESD | 1997-05-02 | 49 |
| K964245 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS | ESD | 1997-02-04 | 103 |
| K964340 | PORTAREM-3000, PFS-6000 | EWO | 1997-01-10 | 71 |
| K964216 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER | KLW | 1996-12-06 | 45 |
| K964244 | STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | ESD | 1996-11-27 | 34 |
| K964214 | STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | ESD | 1996-11-27 | 36 |
| K963995 | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER | KLW | 1996-11-26 | 53 |
51 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Starkey Laboratories, Inc..
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.
Device clinical trials
An industry sponsor named Starkey Laboratories, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07298499: Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus (Enrolling by invitation, started 2025-07-07)
- NCT05612763: Self Fitting Hearing Aid Clinical Investigation (Completed, started 2022-08-18)
- NCT05101083: Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids (Completed, started 2021-10-25)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Starkey Laboratories, Inc. (60)
- Starkey Laboratories (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Starkey Laboratories, Inc.?
FDA lists 61 510(k) clearances under 2 spellings of the applicant name “Starkey Laboratories, Inc.” (first 1977, latest 2020), across 9 product codes in 2 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 Starkey Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Starkey Laboratories, Inc. is 45 days.
Which FDA product codes appear under Starkey Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 39); KLW (Masker, Tinnitus, 10); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 4).
Next steps
- See all 61 Starkey Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Starkey Laboratories, Inc.'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.