Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Int'L Hearing Aids, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
79 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873798 | INTERNATIONAL MODEL XP BEHIND-THE-EAR | Int'L Hearing Aids, Inc. | 1987-10-20 | 32 | 0 |
| K873800 | INTERNATIONAL MODEL XM BEHIND-THE-EAR | Int'L Hearing Aids, Inc. | 1987-10-20 | 32 | 0 |
| K873799 | INTERNATIONAL MODEL XL BEHIND-THE-EAR | Int'L Hearing Aids, Inc. | 1987-10-20 | 32 | 0 |
| K872647 | INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR | Int'L Hearing Aids, Inc. | 1987-08-26 | 50 | 0 |
| K864031 | MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | 29 | 0 |
| K864028 | MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | 29 | 0 |
| K864029 | AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | 29 | 0 |
| K864030 | MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | 29 | 0 |
| K853942 | INT'L MODEL XE BEHIND-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1985-12-18 | 85 | 0 |
| K853941 | INT'L MODEL XG BEHIND-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1985-12-18 | 85 | 0 |
| K853172 | INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI | Int'L Hearing Aids, Inc. | 1985-10-17 | 79 | 0 |
| K853170 | INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID | Int'L Hearing Aids, Inc. | 1985-10-04 | 66 | 0 |
| K853171 | INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A | Int'L Hearing Aids, Inc. | 1985-10-01 | 63 | 0 |
| K853173 | INTERNATION MODEL SS STOCK CANAL IN THE EAR H.A. | Int'L Hearing Aids, Inc. | 1985-09-06 | 38 | 0 |
| K800447 | SEARS ALL-IN-THE-EAR HEARING AID #8149HF | Int'L Hearing Aids, Inc. | 1980-04-08 | 40 | 0 |
| K800446 | SEARS ALL-IN-THE-EAR HEARING AID #8149 | Int'L Hearing Aids, Inc. | 1980-04-08 | 40 | 0 |
| K800113 | SEARS BEHIND-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1980-02-11 | 26 | 0 |
| K790270 | HEARING AID MODEL 8143 | Int'L Hearing Aids, Inc. | 1979-02-27 | 28 | 0 |
| K780820 | HEARING AID MODEL 8148 | Int'L Hearing Aids, Inc. | 1978-05-31 | 12 | 0 |
| K780822 | HEARING AID MODEL 8160U | Int'L Hearing Aids, Inc. | 1978-05-31 | 12 | 0 |
| K780821 | HEARING AID MODEL 8160H | Int'L Hearing Aids, Inc. | 1978-05-31 | 12 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda