Who is the manufacturer of PRECISE IMPRESSION KIT?

Starkey Laboratories, Inc. filed the 510(k) submission for PRECISE IMPRESSION KIT (K970952).

What is the FDA product code for PRECISE IMPRESSION KIT?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for PRECISE IMPRESSION KIT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PRECISE IMPRESSION KIT?

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

Who can help prepare an FDA 510(k) submission like PRECISE IMPRESSION KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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.)

Related Devices

K964245 — PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS · Starkey Laboratories, Inc. · Feb 4, 1997
K973927 — HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL · Hyunjae Corp. · Dec 11, 1997
K121326 — LANTOS 3D EAR SCANNER · Lantos Technologies · Jan 25, 2013
K073384 — SMART COUPLER, MODEL M015401 · Intelligent Hearing Systems · Feb 28, 2008
K031713 — AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS · Viasys Healthcare, Inc. · Aug 12, 2003

Submission Summary (Full Text)

{0} 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 3