AUDALLION II HEARING SYSTEM

K970215 · Resound Corp. · ESD · Mar 31, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970215
• Device Name: AUDALLION II HEARING SYSTEM
• Applicant: Resound Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Mar 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This air-conduction behind-the-ear hearing instrument with body-worn processor 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 severe.

Device Story

Air-conduction behind-the-ear hearing system with body-worn processor; amplifies sound pressure waves for transmission to external ear. Powered by type 13 hearing aid battery and two AAA alkaline batteries. Operated by hearing aid dispenser to program fitting parameters; user adjusts volume and selects from up to four stored programs. Digital sound processing allows customization of acoustic characteristics. Intended to compensate for mild to severe hearing loss.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through comparison of performance specifications and operational functions to predicate device.

Technological Characteristics

Air-conduction behind-the-ear hearing instrument with body-worn processor. Powered by type 13 and dual AAA alkaline batteries. Digital sound processing with programmable fitting parameters. Memory capacity for four programs. Manufactured using standard industry materials and assembly techniques.

Indications for Use

Indicated for individuals with mild to severe hearing loss requiring sound amplification via air-conduction behind-the-ear hearing instrument.

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® BT4 Personal Hearing System™ (K964557)

Submission Summary (Full Text)

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RESOUND® HEARING HEALTH CARE
MAR 31 1997
K970215

# Audallion® II Hearing System

## SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the Audallion® II Hearing System to the predicate device, the ReSound® BT4 Personal Hearing System™, 510(k) No. K964557, Nov. 27, 1996, is based on the following:

- This air-conduction behind-the-ear hearing instrument with body-worn processor 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 severe.

- The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries.

- 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 Audallion® II Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™.

- The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® BT4 Personal Hearing System™, as is the ability to change the characteristics of the sound processing and adjust the volume.

- The Audallion® II Hearing System has the ability to retain up to four programs in memory, whereas the predicate device has the ability to retain two.