Etymotic Research: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Etymotic Research” (first 1984, latest 2015), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 69 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 | 1 | 29 |
| 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 |
|---|---|---|---|
| EWO | Audiometer | 8 | 8 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Ear, Nose and Throat (10)
- Neurology (1)
Most recent Etymotic Research 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150491 | ER36 Series OAE Test System | EWO | 2015-03-26 | 29 |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | EWO | 2011-12-16 | 87 |
| K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | EWO | 2007-06-07 | 69 |
| K011114 | ETYMOTIC RESEARCH ER-10D OAE PROBE | EWO | 2001-07-03 | 82 |
| K010165 | ERO SCAN OAE TEST SYSTEM | EWO | 2001-03-12 | 53 |
| K980533 | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | EWO | 1998-03-23 | 40 |
| K930553 | CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT | EWO | 1993-09-29 | 238 |
| K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | EWO | 1993-06-18 | 165 |
| K873298 | ELEC-TIP | GXY | 1987-11-24 | 98 |
| K861113 | ER-7C CLINICAL PROBE MICROPHONE | ETW | 1986-04-23 | 29 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Etymotic Research.
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 Etymotic Research?
FDA lists 11 510(k) clearances under the applicant name “Etymotic Research” (first 1984, latest 2015), across 4 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 Etymotic Research?
The median time from FDA receipt to decision across 510(k)s cleared under the name Etymotic Research is 69 days.
Which FDA product codes appear under Etymotic Research?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 8); ESD (Hearing Aid, Air-Conduction, Prescription, 1); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 1).
Next steps
- See all 11 Etymotic Research clearances with predicates and recalls
- Run predicate analysis for product code EWO, Etymotic Research'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.