RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

K964557 · Resound Corp. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964557
• Device Name: RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
• Applicant: Resound Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 27, 1996
• 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, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.

Device Story

Behind-the-ear air-conduction hearing instrument; amplifies sound pressure waves for transmission to external ear. Powered by type 13 battery. Operated by hearing aid dispenser/user; features digital programming of fitting parameters; sound processing characteristics adjustable via ultrasound remote control. Retains two programs in memory. Includes Direct Audio Input (DAI) option. Used to compensate for mild to severe hearing loss.

Clinical Evidence

No clinical data; substantial equivalence based on design, performance specifications, and functional similarity to predicate.

Technological Characteristics

Behind-the-ear air-conduction hearing instrument; type 13 battery powered; digital programming of fitting parameters; ultrasound remote control interface; dual-program memory; DAI (Direct Audio Input) capability.

Indications for Use

Indicated for individuals with mild to 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 BT (K912665/A)

Submission Summary (Full Text)

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RESOUND® HEARING HEALTH CARE

NOV 27 1996

K964557

# ReSound® BT4 Personal Hearing System™

# SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the ReSound® BT4 Personal Hearing System™ to the predicate device, the ReSound® Personal Hearing System BT (marketed as the BT2), 510(k) No. K912665/A, July 24, 1991, is based on the following:

- This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to 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® BT4 Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT.

- The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® Personal Hearing System BT, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control. The ReSound® BT4 Personal Hearing System™ and the predicate device have the ability to retain two programs in memory.

- The operation and functioning of the DAI option is identical to that offered by other hearing aid manufacturers.