IN-THE-EAR
Device Facts
| Record ID | K961827 |
|---|---|
| Device Name | IN-THE-EAR |
| Applicant | Qualitone |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Jul 3, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Device Story
DSD K-AMP Option; hearing aid instrument. Input: ambient sound. Processing: traditional sound amplification/processing principles. Output: amplified sound for user. Used in clinical or daily settings by hearing-impaired patients. Device provides auditory assistance; improves sound perception for users.
Clinical Evidence
Bench testing only; performance meets ANSI S-3.22 1987 requirements.
Technological Characteristics
Hearing aid instrument; traditional sound processing; performance compliant with ANSI S-3.22 1987.
Indications for Use
Indicated for individuals requiring hearing assistance via hearing aid instruments.
Regulatory Classification
Identification
An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
Reference Devices
- Qualitone hearing aid devices
Related Devices
- K972058 — LORIPRO, LORIPRO II · Lori Medical Laboratories, Inc. · Aug 15, 1997
- K963915 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION · Telex Communications, Inc. · Nov 8, 1996
- K972542 — JAZZ PP AGC-O, JAZZ PP · Trutone · Jul 23, 1997
- K964530 — DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT · Miracle-Ear, Inc. · Nov 27, 1996
- K971535 — WIDEX SENSO DIGITAL (MINI CANAL) · Widex Hearing Aid Co., Inc. · Jun 6, 1997
