Nu-Ear Electronics: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Nu-Ear Electronics” (first 1994, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time under this name: 77 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 | 10 | 10 |
Review panels
- Ear, Nose and Throat (10)
Most recent Nu-Ear Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935335 | NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID | ESD | 1994-01-21 | 77 |
| K935334 | NU.EAR SD-1 IN THE EAR (ITE) HEARING AID | ESD | 1994-01-21 | 77 |
| K935333 | NU.EAR SS-1 IN THE EAR (ITE) HEARING AID | ESD | 1994-01-21 | 77 |
| K935332 | NU.EAR AE-1 IN THE EAR (ITE) HEARING AID | ESD | 1994-01-21 | 77 |
| K935331 | NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID | ESD | 1994-01-21 | 77 |
| K935330 | NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID | ESD | 1994-01-21 | 77 |
| K935329 | NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID | ESD | 1994-01-21 | 77 |
| K935328 | NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID | ESD | 1994-01-21 | 77 |
| K935327 | NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID | ESD | 1994-01-21 | 77 |
| K935326 | NU-EAR SD-10 IN THE CANAL HEARING AID | ESD | 1994-01-21 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Nu-Ear Electronics.
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 Nu-Ear Electronics?
FDA lists 10 510(k) clearances under the applicant name “Nu-Ear Electronics” (first 1994, latest 1994), 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 Nu-Ear Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nu-Ear Electronics is 77 days.
Which FDA product codes appear under Nu-Ear Electronics?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 10).
Next steps
- See all 10 Nu-Ear Electronics clearances with predicates and recalls
- Run predicate analysis for product code ESD, Nu-Ear Electronics'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.