Improved Hearing Service, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Improved Hearing Service, Inc.” (first 1990, latest 1990), across 1 product code in 1 review panel. Median 510(k) review time under this name: 71 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 | 9 | 9 |
Review panels
Most recent Improved Hearing Service, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903865 | ITE HEARING AID, SOUND MED AMETHYST MODEL | ESD | 1990-10-09 | 71 |
| K903864 | ITE HEARING AID, PEARL MODEL | ESD | 1990-10-09 | 71 |
| K903863 | ITE HEARING AID, SOUND MED OPAL MODEL | ESD | 1990-10-09 | 71 |
| K903862 | ITE HEARING AID, SOUND MED RUBY MODEL | ESD | 1990-10-09 | 71 |
| K903861 | ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL | ESD | 1990-10-09 | 71 |
| K903860 | ITE HEARING AID, SAAPHIRE MODEL | ESD | 1990-10-09 | 71 |
| K903859 | ITE HEARING AID, DIAMOND MODEL | ESD | 1990-10-09 | 71 |
| K903415 | ITE HEARING AID, SOUND MED EMERALD MODEL | ESD | 1990-10-09 | 71 |
| K902290 | ITE HEARING AID MODEL PALOMINO | ESD | 1990-08-01 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Improved Hearing Service, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Improved Hearing Service, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Improved Hearing Service, Inc.” (first 1990, latest 1990), 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 Improved Hearing Service, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Improved Hearing Service, Inc. is 71 days.
Which FDA product codes appear under Improved Hearing Service, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 9).
Next steps
- See all 9 Improved Hearing Service, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Improved Hearing Service, 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, 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.