ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER

K962012 · Ethical Hearing Instruments · EWO · Aug 21, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962012
• Device Name: ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
• Applicant: Ethical Hearing Instruments
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Aug 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The Wizard Loudness Growth Tester is intended to be used as a loudness growth tester.

Device Story

Wizard Loudness Growth Tester; assesses hearing sensitivity via loudness growth testing. Device operates on traditional principles for loudness growth measurement; meets ANSI S3.6-1989 performance requirements. Used in clinical settings by audiologists or hearing health professionals. Input involves auditory stimuli; output provides loudness growth data to assist clinicians in fitting hearing instruments and evaluating patient dynamic range. Device design and user controls mirror existing marketed loudness growth testers.

Clinical Evidence

Bench testing only; performance meets ANSI S3.6-1989 requirements.

Technological Characteristics

Loudness growth tester; performance compliant with ANSI S3.6-1989. Traditional principle of operation; standard user controls.

Indications for Use

Indicated for patients requiring loudness growth testing to assess hearing sensitivity and dynamic range.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Submission Summary (Full Text)

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Ethical Hearing Instruments
90 Fleet Street Portsmouth, NH 03801
603-430-1024 603-436-3220 (fax)
AUG 21 1996
K962012

# Safety and Effectiveness

## DRAERD 510 (k) Summary/Statement Certification for Wizard Loudness Growth Tester

The summary of information, new product to present products demonstrates substantial equivalence as required by the “Safe Medical Devices Act (SMDA)” of 1990. The design follows traditional principles of operation for Loudness Growth Testers. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S3.6-1989. User controls and methods are similar to others currently being marketed.