Who is the manufacturer of RESOUND CC4 PERSONAL HEARING SYSTEM?

Resound Corp. filed the 510(k) submission for RESOUND CC4 PERSONAL HEARING SYSTEM (K964115).

What is the FDA product code for RESOUND CC4 PERSONAL HEARING SYSTEM?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for RESOUND CC4 PERSONAL HEARING SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RESOUND CC4 PERSONAL HEARING SYSTEM?

ReSound® Personal Hearing System™ ED4-C (IC4) (K951067).

Who can help prepare an FDA 510(k) submission like RESOUND CC4 PERSONAL HEARING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RESOUND CC4 PERSONAL HEARING SYSTEM

K964115 · Resound Corp. · ESD · Nov 4, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K964115
Device Name	RESOUND CC4 PERSONAL HEARING SYSTEM
Applicant	Resound Corp.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Nov 4, 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 moderate.

Device Story

Air-conduction hearing instrument; amplifies sound pressure waves; transmits signal to external ear. Powered by type 10A battery. Dispensed by hearing aid professionals. Features digital programmability of fitting parameters; optional remote control for volume and sound processing adjustments. Device compensates for mild to moderate hearing loss.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and functional comparison to predicate device.

Technological Characteristics

Air-conduction hearing instrument; powered by type 10A battery; digital sound processing; programmable fitting parameters; optional remote control interface.

Indications for Use

Indicated for individuals with mild to moderate hearing loss requiring 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™ ED4-C (IC4) (K951067)

Related Devices

K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION · Resound Corp. · Jul 3, 1997
K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION · Resound Corp. · Nov 27, 1996
K970215 — AUDALLION II HEARING SYSTEM · Resound Corp. · Mar 31, 1997
K960494 — EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS · Starkey Laboratories, Inc. · Mar 1, 1996
K955930 — BELTONE COMPOSER 2000 BTE HP · Beltone Electronics Corp. · Mar 1, 1996

Submission Summary (Full Text)

{0} K964115 RESOUND® HEARING HEALTH CARE NOV 4 1996 # ReSound® CC4 Personal Hearing System™ ## SUMMARY OF SAFETY AND EFFECTIVENESS Substantial equivalence of the ReSound® CC4 Personal Hearing System™ to the ReSound® Personal Hearing System™ ED4-C (now known as the IC4), 510(k) No. K951067, May 12, 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 moderate. - The device is powered by a standard hearing aid battery (type 10A). - 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 ability of the hearing aid dispenser to program digitally the fitting parameters of the ReSound® CC4 hearing device is the same as in the ReSound® IC4. - The ability to change the characteristics of the sound processing and to adjust the volume via an optional remote control is the same as that offered by the commercial device, the ReSound® IC4. - The algorithm used by the ReSound® computerized fitting system to compute sets of fitting parameters is similar to that used for the ReSound® IC4 with adjustments made for the acoustic differences between the IC4 and the ReSound® CC4. - The performance specifications, functions and operations of the ReSound® CC4 Personal Hearing System™ is substantially equivalent to that described in the predicate device 510(k) Premarket Notification.