PRECISE IMPRESSION KIT

K970952 · Starkey Laboratories, Inc. · ESD · May 2, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970952
• Device Name: PRECISE IMPRESSION KIT
• Applicant: Starkey Laboratories, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: May 2, 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

Precise Impression Kit; used by hearing health professionals to create ear/ear canal imprints. Kit components mixed by clinician; inserted into patient ear to capture anatomical geometry. Features include smooth consistency, quick drying, non-allergenic material, and pleasant scent. Output is physical ear mold impression used for custom hearing aid fabrication. Facilitates accurate fit of hearing devices.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Impression material kit; non-allergenic; quick-drying; smooth consistency. Technical specifications and material composition detailed in provided Material Safety Data Sheets.

Indications for Use

Indicated for individuals requiring ear and ear canal impressions for hearing aid fitting or related audiological services.

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

• Silhouette™ Premium Impression System (Siemens Hearing Instruments, Inc.)
• Matrics Impression System (Matrics, Inc.)

Submission Summary (Full Text)

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MAY - 2 1997
K970952

# SAFETY AND EFFECTIVENESS SUMMARY - PRECISE IMPRESSION KIT

NAME OF DEVICE: Precise Impression Kit.

TYPE OF DEVICE: Impression Kits, -- Substantially equivalent to the Silhouette™ Premium Impression System from Siemens Hearing Instruments, Inc. and the Matrics Impression System from Matrics, Inc.

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.

3/13/97

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