RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241

K960052 · Resound Corp. · ESD · Mar 12, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960052
• Device Name: RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
• Applicant: Resound Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, are designed for hearing losses from mild to moderately-severe.

Device Story

Air-conduction hearing instruments; amplify/transmit sound to ear; powered by type 13 battery; dispenser-programmable (BT2-ES, BT2-EV) or factory-preset (BT241); retain programming during battery changes; used by hearing aid dispensers to fit patients; improves auditory perception for hearing-impaired users.

Clinical Evidence

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

Technological Characteristics

Air-conduction hearing instruments; type 13 battery powered; digital programming of fitting parameters; non-volatile memory for program retention; assembled using standard industry materials and manufacturing techniques.

Indications for Use

Indicated for individuals with mild to moderately-severe hearing loss requiring sound amplification and transmission.

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 BT2-C (BT2-E Encore) (K943788)

Submission Summary (Full Text)

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RESOUND® HEARING HEALTH CARE

K960052

# ReSound® Personal Hearing System BT2-ES, BT2-EV, and BT241

## SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the ReSound® Personal Hearing Systems BT2-ES, BT2-EV, and BT241 to the predicate device, the ReSound® Personal Hearing System BT2-C, (marketed as the BT2-E Encore), 510(k) No. K943788, September 21, 1994, is based on the following:

- These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, are designed 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 BT2-ES, BT2-EV, and BT241 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT2-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 BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.

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