(68 days)
To amplify and deliver sound to the ear.
BTE Hearing Aid
The provided text describes a 510(k) summary for the "PrimoFocus Compact" BTE Hearing Aid. However, it does not contain any information about acceptance criteria, device performance metrics, or study details as requested in the prompt.
Therefore, I cannot provide the requested information from the given input. The document is a regulatory submission summary outlining the device's basic features and intended use, not a detailed study report.
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K9603-788
NOV 27 1996
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OTICON, INC. 29 Schoolhouse Road P.O. Box 6724 Somerset, NJ 08875-6724 Toll-Free 1-800-526-3921 FAX (908) 560-0029
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| NAME OF DEVICE: | PrimoFocus Compact |
|---|---|
| TYPE OF DEVICE: | BTE Hearing Aid |
| INTENDED USE: | To amplify and deliver sound to the ear. |
| FEATURES: | 47 Db HFA gain, single band compression amplifier with dualtime constants and variable compression threshold, utilizes classD output amplifier. |
| ASSEMBLY: | Assembled from standard electronic hearing aid componentsmounted together with a custom microchip/hybrid. |
| TECHNICALCHARACTERISTICS: | Technical specifications are in accordance with ANSI StandardsS3.22-1987 |
| FITTING CRITERIA: | Frequency response, compression threshold, gain and SSPL 90 isdictated by individual audiometric and patient history data. |
| ADJUSTMENTS/CONTROLS: | All parameters are adjusted via manual controls. |
| POWER SOURCE: | Standard type 13 battery. |
A USER INSTRUCTIONAL BROCHURE AND ADJUSTMENT INSTRUCTIONS ARE SUPPLIED WITH EACH HEARING AID.
§ 874.3300 Air-conduction hearing aid.
(a)
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.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.