HEARING AID - AIR CONDUCTION

K960684 · Resound Corp. · ESD · Apr 10, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960684
• Device Name: HEARING AID - AIR CONDUCTION
• Applicant: Resound Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Apr 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

Device Story

Air-conduction hearing instrument; amplifies sound pressure waves; transmits signal to external ear. Powered by type 13 battery. Used by hearing aid dispensers to fit patients. Features digital programming of fitting parameters; retains program settings during battery changes. Seven factory-preset programs available for selection; dispenser cannot modify presets; modifications require factory intervention. Benefits patient by compensating for hearing loss.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Air-conduction hearing instrument; powered by type 13 battery. Digital programming of fitting parameters; non-volatile memory for program retention. Seven factory-preset programs. Materials and assembly techniques standard to hearing aid industry.

Indications for Use

Indicated for individuals with mild to moderately-severe hearing loss requiring air-conduction sound amplification.

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.

Predicate Devices

• ReSound® Personal Hearing System ED3-E (K950319)

Submission Summary (Full Text)

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RESOUND®
HEARING HEALTH CARE
APR 10 1996
15960684

# ReSound® Personal Hearing System EDR-7

## SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the ReSound® Personal Hearing System EDR-7 to the predicate device, the ReSound® Personal Hearing System ED3-E, 510(k) No. K950319, February 8, 1995, is based on the following:

- This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.

- The device is powered by a standard hearing aid battery (type 13).

- The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.

- The intended use, performance specifications, functions and operations of the ReSound® Personal Hearing System EDR-7 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System ED3-E.

- The ability to program digitally the fitting parameters of the hearing device and the ability of the device to retain the program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. Seven programs are factory preset for the EDR-7 from which the dispenser may select for the fitting. The seven factory preset programs may not be modified by the dispenser via a programmer or by any other means. Modifications in the preset programming may only be accomplished at the factory.

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