FDA product code KHL: Hearing Aid, Master
KHL is the FDA product code for hearing aid, master. It is a Class II device, regulated under 21 CFR 874.3330 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 7 510(k) submissions under KHL, from 7 different applicants. The average 510(k) review took 91 days (median 99).
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Master |
| Device class | Class II |
| Regulation | 21 CFR 874.3330 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KHL clearance
Top KHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lori Medical Laboratories, Inc. | 1 | 1997-01-08 |
| Bausch & Lomb, Inc. | 1 | 1991-10-23 |
| Resound Corp. | 1 | 1989-09-21 |
| Voroba Technologies Assoc. | 1 | 1986-05-02 |
| Craigwell Electronics, Ltd. | 1 | 1986-01-16 |
2 more applicants have KHL clearances. See the full list in Caduvo.
Most recent KHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964080 | Lori Medical Laboratories, Inc. | LORI HEARING AID SIMULATOR | 1997-01-08 | 89 |
| K911726 | Bausch & Lomb, Inc. | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION | 1991-10-23 | 195 |
| K894019 | Resound Corp. | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | 1989-09-21 | 107 |
| K860171 | Voroba Technologies Assoc. | VOROBA PROGRAMMABLE AUDITORY COMPARATOR | 1986-05-02 | 105 |
| K854126 | Craigwell Electronics, Ltd. | CRAIGWELL MASTER HEARING AID MHA | 1986-01-16 | 99 |
Recalls for KHL devices
openFDA lists no recalls for product code KHL.
Frequently asked questions
What is FDA product code KHL?
KHL is the FDA product code for hearing aid, master. It is a Class II device, regulated under 21 CFR 874.3330 and reviewed by the Ear, Nose and Throat panel.
What device class is KHL?
Class II, regulation 21 CFR 874.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHL?
Across 7 cleared submissions the average was 91 days from receipt to decision (median 99).
Which companies have the most KHL clearances?
Lori Medical Laboratories, Inc. (1); Bausch & Lomb, Inc. (1); Resound Corp. (1); Voroba Technologies Assoc. (1); Craigwell Electronics, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHL
- Run a recall and safety report across every KHL manufacturer
- Watch product code KHL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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