PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS

K964245 · Starkey Laboratories, Inc. · ESD · Feb 4, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K964245
• Device Name: PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
• Applicant: Starkey Laboratories, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1

Intended Use

To obtain an accurate imprint of an individual ear and ear canal.

Device Story

Impression kits provide tools for Hearing Health Professionals to create ear/ear canal imprints. Kit contains impression materials; professional mixes and assembles components. Material properties include smooth consistency, ease of insertion, non-allergenic, pleasant scent, quick drying, and easy cleanup. Used in clinical settings by audiologists or hearing aid dispensers to facilitate custom device fitting.

Clinical Evidence

No clinical data provided; equivalence based on material comparison to predicate.

Technological Characteristics

Impression material kit; non-allergenic formulation; physical properties include smooth consistency and quick drying. Technical specifications provided via Material Safety Data Sheets (MSDS).

Indications for Use

Indicated for use by Hearing Health Professionals to obtain an accurate imprint of an individual ear and ear canal for patients requiring custom ear molds or hearing aid fittings.

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

• Audalin Liquid and Impression Polymer (exempt)

Submission Summary (Full Text)

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FEB - 4 1997
x964245

# SUMMARY-- PRECISE, TYMPANETTE, AND XACTO IMPRESSION KIT SUBSTANTIAL EQUIVALENCE

The above mentioned impression kits are designed to provide the tools necessary for a Hearing Health Professional to obtain an accurate imprint of an individual ear and ear canal. The Hearing Health Professional receives materials in the form of a kit, and is responsible for any mixing of materials, or assembly of components for usage.

Impression material is handled in bulk form, prior to being packaged in kits. This material, whether in bulk or kit form, is identical. The material in the impression kits are substantially equivalent to Audalin Liquid and Impression Polymer. (There is no 510(k) for the Audalin impression material as it is exempt because it was in commercial distribution prior to 5/28/96.) 1996?

## Impression Kits

- Smooth Consistency
- Ease of Insertion
- Non-Allergenic Properties
- Pleasant Scent
- Quick Drying Time
- Ease in Clean Up

## Audalin Liquid/Impression Polymer

- Smooth Consistency
- Ease of Insertion
- Non-Allergenic Properties
- Pleasant Scent
- Quick Drying Time
- Ease in Clean Up

10/18/96

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# SAFETY AND EFFECTIVENESS SUMMARY - PRECISE, TYMPANETTE, AND XACTO IMPRESSION KITS

NAME OF DEVICE: Precise, Tympanette and Xacto Impression Kits.

TYPE OF DEVICE: Impression Kits, -- Substantially equivalent to Audalin Liquid and Audalin Impression Polymer.

INTENDED USE: To obtain an accurate imprint of an individual ear and ear canal.

FEATURES: Smooth consistency, ease of insertion, non-allergenic properties, pleasant scent, quick drying time, easy clean up.

ASSEMBLY: Kits are assembled for Hearing Health Professionals, who are responsible for any mixing of materials or assembly of components for usage.

TECHNICAL CHARACTERISTICS: Material Safety Data Sheets are included for description of technical characteristics.

10/18/96