ARTICULAR HEARING AIDS

K964603 · Decibel Instruments, Inc. · ESD · Dec 6, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964603
• Device Name: ARTICULAR HEARING AIDS
• Applicant: Decibel Instruments, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Dec 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.

Device Story

Articulate G1 Series Hearing Aids are air-conduction devices for in-the-canal to deep-canal fitting. Microphone converts sound waves to electrical signals; circuit amplifies signal; receiver delivers sound to tympanic membrane. Non-programmable models use manual potentiometers for amplification adjustment; programmable models use digitally programmable memory adjusted via PC interface and proprietary software. Operated by hearing aid dispensers to customize amplification characteristics for patient needs. Devices feature faceplate switches for volume control. Benefits include improved sound perception for hearing-impaired users.

Clinical Evidence

Bench testing only. Performance characteristics evaluated per ANSI S3.22-1996, "Specification of Hearing Aid Characteristics." Devices met all manufacturer-developed specifications using test methods outlined in the standard.

Technological Characteristics

Air-conduction hearing aid; in-the-canal to deep-canal form factor. Electronics external to second bend of ear canal; receiver located around second bend. Non-programmable: potentiometer-based amplification. Programmable: digitally programmable memory, PC-interface connectivity. Powered by battery. Performance tested per ANSI S3.22-1996.

Indications for Use

Indicated for individuals with impaired hearing requiring sound amplification to compensate for hearing loss.

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

• Starkey Laboratories Tympanette (K933407)
• General Hearing Instruments In-the-Ear Hearing Aid (K850123)
• Resound Corporation Resound ITE Hearing Enhancement System (HES) (K884871)

Submission Summary (Full Text)

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Decibel
X964603
DEC - 6 1996

# SECTION 2

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

**Submitter's Name:** Decibel Instruments, Inc.
3857 Breakwater Avenue
Hayward, CA 94545 USA
Telephone: [phone]
**Contact Person:** Adnan Shennib, President

**Date of Summary:** November 18, 1996

**Device Name:** Articulate™ G1 Series Hearing Aids

**Legally Marketed Devices To Which Equivalence Is Claimed:** The legally marketed predicate devices to which equivalence is claimed are:

- The Starkey Laboratories Tympanette (K933407), determined to be substantially equivalent to a pre-enactment device on October 7, 1993;
- The General Hearing Instruments In-the-Ear Hearing Aid (K850123), determined to be substantially equivalent to a pre-enactment device on March 21, 1985; and
- The Resound Corporation Resound ITE Hearing Enhancement System (HES) (K884871), determined to be substantially equivalent to a pre-enactment device on February 21; 1989.

**Device Description:** The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.

Decibel Instruments, Inc. • 3857 Breakwater Avenue • Hayward, CA 94545 • Tel: [phone] • Fax: [phone]
25

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Decibel

Intended Use: The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.

## Descriptive Summary Of Technological Characteristics And Those Of Predicate Devices:

The non-programmable Articulate G1 Series models (G1-12-MM, G1-12-MS, G1-24-MM, and G1-24-MS) are air conduction hearing aids, with in-the-canal to deep canal fitting. Electronics are external to the second bend of the ear canal, with receiver located around the second bend, transmitting sound to the tympanic membrane. The potentiometers of the circuit are used to change the amplification characteristics of the incoming signal. Two volume control settings are modified by a switch on the faceplate. These characteristics are similar to the Starkey Laboratories Tympanette and to the General Hearing Instruments In-the-Ear Hearing Aid (EZ-Ear).

The programmable Articulate G1 Series models (G1-P24-MM, and G1-P24-MS) are air conduction hearing aids, with in-the-canal to deep canal fitting. Electronics are external to the second bend of the ear canal, with receiver located around the second bend, transmitting sound to the tympanic membrane. Amplification characteristics are contained in digitally programmable memory and direct programming of hearing aid circuit occurs through interface to a personal computer and and programming software. Two volume control settings are modified by a switch on the faceplate. These characteristics are similar to the General Hearing Instruments In-the-Ear Hearing Aid (EZ-Ear) and to the Resound ITE Hearing Enhancement System (HES).

Performance data: The performance characteristics of the Articulate G1 Series Hearing Aids have been evaluated in accordance with ANSI S3.22-1996, “Specification of Hearing Aid Characteristics”. The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in the specification.



Decibel Instruments, Inc. • 3857 Breakwater Avenue • Hayward, CA 94545 • Tel: [phone] • Fax: [phone]