Who is the manufacturer of DAHLBERG K-AMP BTE?

Miracle-Ear, Inc. filed the 510(k) submission for DAHLBERG K-AMP BTE (K964794).

What is the FDA product code for DAHLBERG K-AMP BTE?

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 DAHLBERG K-AMP BTE?

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

What are the predicate devices for DAHLBERG K-AMP BTE?

Miracle-Ear K-AMP Circuits (K954941).

Who can help prepare an FDA 510(k) submission like DAHLBERG K-AMP BTE?

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.

DAHLBERG K-AMP BTE

K964794 · Miracle-Ear, Inc. · ESD · Dec 23, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K964794
Device Name	DAHLBERG K-AMP BTE
Applicant	Miracle-Ear, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Dec 23, 1996
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. Used by patients with mild to severe hearing loss. Clinician fits device based on individual audiogram. Device utilizes standard industry materials and assembly practices.

Clinical Evidence

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

Technological Characteristics

BTE hearing aid; Zinc-Air size 13 battery power; ANSI S3.22-1987 testing methodology; industry-standard case materials.

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

Miracle-Ear K-AMP Circuits (K954941)

Related Devices

K965049 — DAHLBERG (A-554) · Miracle-Ear, Inc. · Jan 27, 1997
K965057 — AUDIOTONE (A554H) · Miracle-Ear, Inc. · Jan 27, 1997
K970262 — MULTI-CHANNEL COMPRESSION BTE (SD) · Miracle-Ear, Inc. · Mar 31, 1997
K965063 — AUDIOTONE (A-552) · Miracle-Ear, Inc. · Jan 27, 1997
K964669 — MIRACLE-EAR OR AUDIOTONE · Miracle-Ear, Inc. · Dec 26, 1996

Submission Summary (Full Text)

{0} K964794 Appendix B DEC 23 1996 # Summary of Safety and Effectiveness - **Device Name:** Dahlberg K-AMP BTE - **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:** Miracle-Ear K-AMP Circuits which was cleared for distribution under document control number K954941. - **Registration Number:** 2110592 - **Materials:** The hearing aid cases 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.