RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1

K960680 · Resound Corp. · ESD · Apr 10, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960680
• Device Name: RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1
• 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

These air-conduction hearing instruments are 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 instruments (Models EDR-E, EDR-ES, EDR-EV, EDR-P1); amplify sound pressure waves; transmit signal to external ear. Powered by type 13 battery. Dispenser-programmable fitting parameters (EDR-E, EDR-ES, EDR-EV) or factory-preset (EDR-P1); non-volatile memory retains program during battery changes. Used by hearing aid dispensers to compensate for hearing loss; improves patient auditory perception.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications.

Technological Characteristics

Air-conduction hearing instruments; powered by type 13 battery. Digital programming of fitting parameters; non-volatile memory for program retention. Models EDR-E, EDR-ES, EDR-EV are dispenser-programmable; EDR-P1 is factory-preset. Standard hearing aid materials and assembly techniques.

Indications for Use

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

29160680

APR 10 1996

# ReSound® Personal Hearing Systems EDR Encore Series

## SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the ReSound® Personal Hearing Systems EDR Encore Series: Models EDR-E, EDR-ES, EDR-EV, and EDR-P1 to the predicate device, the ReSound® Personal Hearing System ED3-E, 510(k) No. K950319, February 8, 1995, is based on the following:

- These air-conduction hearing instruments are 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.

- These devices are powered by a standard hearing aid battery (type 13).

- These devices are 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 Systems EDR Encore Series 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 devices and the ability of the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. The EDR-E, EDR-ES, and EDR-EV are dispenser programmable, whereas the EDR-P1 programming is factory preset and may be reprogrammed at the factory only.