KHL · Hearing Aid, Master
Ear, Nose, Throat · 21 CFR 874.3330 · Class 2
Overview
| Product Code | KHL |
|---|---|
| Device Name | Hearing Aid, Master |
| Regulation | 21 CFR 874.3330 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964080 | LORI HEARING AID SIMULATOR | Lori Medical Laboratories, Inc. | Jan 8, 1997 | SESE |
| K911726 | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION | Bausch & Lomb, Inc. | Oct 23, 1991 | SESE |
| K894019 | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | Resound Corp. | Sep 21, 1989 | SESE |
| K860171 | VOROBA PROGRAMMABLE AUDITORY COMPARATOR | Voroba Technologies Assoc. | May 2, 1986 | SESE |
| K854126 | CRAIGWELL MASTER HEARING AID MHA | Craigwell Electronics, Ltd. | Jan 16, 1986 | SESE |
| K802812 | RIONET HEARING AID | Kindel & Anderson | Nov 26, 1980 | SESE |
| K790481 | MODEL FS1 | Starkey Laboratories, Inc. | Apr 3, 1979 | SESE |
Top Applicants
- Bausch & Lomb, Inc. — 1 clearance
- Craigwell Electronics, Ltd. — 1 clearance
- Kindel & Anderson — 1 clearance
- Lori Medical Laboratories, Inc. — 1 clearance
- Resound Corp. — 1 clearance
