Hearing Aid, Master
Master Hearing Aid is a diagnostic device used by audiologists to simulate and evaluate a patient's potential benefit from hearing aid amplification; it typically consists of a programmable wearable amplifier that can be adjusted to test various amplification parameters before prescribing a permanent hearing aid. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHL, regulated under 21 CFR 874.3330, within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- KHL
- Device Class
- FDA class 2
- Regulation Number
- 874.3330
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964080 | LORI HEARING AID SIMULATOR | Jan 08, 1997 | Substantially Equivalent | Lori Medical Laboratories, Inc. |
| K911726 | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION | Oct 23, 1991 | Substantially Equivalent | Bausch & Lomb, Inc. |
| K894019 | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | Sep 21, 1989 | Substantially Equivalent | Resound Corp. |
| K860171 | VOROBA PROGRAMMABLE AUDITORY COMPARATOR | May 02, 1986 | Substantially Equivalent | Voroba Technologies Assoc. |
| K854126 | CRAIGWELL MASTER HEARING AID MHA | Jan 16, 1986 | Substantially Equivalent | Craigwell Electronics, Ltd. |
| K802812 | RIONET HEARING AID | Nov 26, 1980 | Substantially Equivalent | Kindel & Anderson |
| K790481 | MODEL FS1 | Apr 03, 1979 | Substantially Equivalent | Starkey Laboratories, Inc. |