← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K970952

# PRECISE IMPRESSION KIT (K970952)

_Starkey Laboratories, Inc. · ESD · May 2, 1997 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970952

## Device Facts

- **Applicant:** Starkey Laboratories, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** May 2, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## 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.

## Regulatory 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)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970952](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970952)

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