Who is the manufacturer of MULTI-CHANNEL COMPRESSION BTE (SD)?

Miracle-Ear, Inc. filed the 510(k) submission for MULTI-CHANNEL COMPRESSION BTE (SD) (K970262).

What is the FDA product code for MULTI-CHANNEL COMPRESSION BTE (SD)?

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 MULTI-CHANNEL COMPRESSION BTE (SD)?

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

What are the predicate devices for MULTI-CHANNEL COMPRESSION BTE (SD)?

Dahlberg multi-channel compression BTE hearing aids (K964530).

Who can help prepare an FDA 510(k) submission like MULTI-CHANNEL COMPRESSION BTE (SD)?

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.

MULTI-CHANNEL COMPRESSION BTE (SD)

K970262 · Miracle-Ear, Inc. · ESD · Mar 31, 1997 · Ear, Nose, Throat

Device Facts

Record ID	K970262
Device Name	MULTI-CHANNEL COMPRESSION BTE (SD)
Applicant	Miracle-Ear, Inc.
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

To amplify and transmit sound to the ear.

Device Story

BTE hearing aid; amplifies and transmits sound to ear; powered by Zinc-Air size 13 battery; intended for patients with mild to severe hearing loss; device utilizes multi-channel compression circuit; clinician-fitted based on user audiogram; benefits patient by improving sound perception.

Clinical Evidence

Bench testing only; performance data obtained using ANSI S3.22-1987 methodology.

Technological Characteristics

BTE hearing aid; multi-channel compression circuit; Zinc-Air size 13 battery; shell materials standard to industry; performance testing per ANSI S3.22-1987.

Indications for Use

Indicated for individuals with mild to severe hearing loss as determined by an audiogram.

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

Dahlberg multi-channel compression BTE hearing aids (K964530)

Related Devices

K964794 — DAHLBERG K-AMP BTE · Miracle-Ear, Inc. · Dec 23, 1996
K965057 — AUDIOTONE (A554H) · Miracle-Ear, Inc. · Jan 27, 1997
K965049 — DAHLBERG (A-554) · Miracle-Ear, Inc. · Jan 27, 1997
K965063 — AUDIOTONE (A-552) · Miracle-Ear, Inc. · Jan 27, 1997
K964530 — DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT · Miracle-Ear, Inc. · Nov 27, 1996

Submission Summary (Full Text)

{0} K970262 Appendix B # MAR 31 1997 ## Summary of Safety and Effectiveness - **Device Name:** Dahlberg Hearing Aid with multi-channel compression circuit - **Device Type:** BTE Hearing Aid - **Classification:** Air Conduction Hearing Aid (77ESD), Class I. - **Intended Use:** To amplify and transmit sound to the ear. - **Substantially Equivalent to:** Dahlberg multi-channel compression BTE hearing aids which were cleared for distribution under document control number K964530. - **Registration Number:** 2110592 - **Materials:** The hearing aid shells will be manufactured from materials that are commonly used in the industry. - **Assembly:** The hearing aid will be assembled utilizing similar assembly practices as Dahlberg's current products. - **Technical Characteristics:** Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids. - **Fit:** Mild to severe as dictated by the individual users audiogram. - **Power:** Zinc-Air size 13 battery.