Int'L Hearing Aids, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Int'L Hearing Aids, Inc.” (first 1978, latest 1987), across 1 product code in 1 review panel. Median 510(k) review time under this name: 32 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 | 21 | 21 |
Review panels
- Ear, Nose and Throat (21)
Most recent Int'L Hearing Aids, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873800 | INTERNATIONAL MODEL XM BEHIND-THE-EAR | ESD | 1987-10-20 | 32 |
| K873799 | INTERNATIONAL MODEL XL BEHIND-THE-EAR | ESD | 1987-10-20 | 32 |
| K873798 | INTERNATIONAL MODEL XP BEHIND-THE-EAR | ESD | 1987-10-20 | 32 |
| K872647 | INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR | ESD | 1987-08-26 | 50 |
| K864031 | MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID | ESD | 1986-11-13 | 29 |
| K864030 | MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID | ESD | 1986-11-13 | 29 |
| K864029 | AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID | ESD | 1986-11-13 | 29 |
| K864028 | MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID | ESD | 1986-11-13 | 29 |
| K853942 | INT'L MODEL XE BEHIND-THE-EAR HEARING AID | ESD | 1985-12-18 | 85 |
| K853941 | INT'L MODEL XG BEHIND-THE-EAR HEARING AID | ESD | 1985-12-18 | 85 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Int'L Hearing Aids, 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 Int'L Hearing Aids, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Int'L Hearing Aids, Inc.” (first 1978, latest 1987), 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 Int'L Hearing Aids, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Int'L Hearing Aids, Inc. is 32 days.
Which FDA product codes appear under Int'L Hearing Aids, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 21).
Next steps
- See all 21 Int'L Hearing Aids, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Int'L Hearing Aids, 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.