INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
K961593 · Segi Hearing Aid Co. · LRB · Nov 7, 1996 · Ear, Nose, Throat
Device Facts
Record ID
K961593
Device Name
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
Applicant
Segi Hearing Aid Co.
Product Code
LRB · Ear, Nose, Throat
Decision Date
Nov 7, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.3300
Device Class
Class 1
Attributes
Therapeutic
Indications for Use
The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.
Device Story
Intrastar pre-wired faceplates function as components for in-the-ear hearing aids; device amplifies sound pressure waves; transmits signal to external ear via air conduction; compensates for hearing impairment; intended for use by patients with hearing loss; operated by hearing healthcare professionals during fitting/assembly; output provides amplified sound to assist patient communication and auditory perception.
Clinical Evidence
No clinical data; substantial equivalence based on bench testing and comparison of performance characteristics to predicate devices.
Technological Characteristics
In-the-ear hearing aid pre-wired faceplates; analog amplification circuitry; frequency range 200-8000 Hz; maximum SSPL90 124.8-133.2 dB; full-on gain 38.3-55.4 dB; battery current 0.74-1.37 mA.
Indications for Use
Indicated for individuals with impaired hearing requiring sound amplification via in-the-ear hearing aid devices.
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
Resound In-The-Ear Hearing Enhancement System (K884871)
K974211 — OPUS 2 - FULL CONCHA SERIES - ITE · Bernafon-Maico, Inc. · Dec 15, 1997
K972058 — LORIPRO, LORIPRO II · Lori Medical Laboratories, Inc. · Aug 15, 1997
K971845 — HEARTLAND TECHNOLOGIES, ITE, ITC, CIC · Sound Hearing Instruments, Inc. · Aug 15, 1997
K974152 — OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) · Bernafon-Maico, Inc. · Dec 15, 1997
K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION · Resound Corp. · Jul 3, 1997
Submission Summary (Full Text)
{0}
K961593
NOV - 7 1996
501(k) Summary
Date: April 10, 1996
Submission contact person:
Leo Weinberger, Esq.
24 Fifth Avenue, New York, N.Y. 10011
(212) 228-4404; Fax: (212) 598-0904
The following information is submitted for approval as required by Title 21, Code of Federal Regulations, Subchapter H-Medical Devices, Subpart E, Paragraph 807.81-Premarket Notification.
Device names:
Trade names: Intrastar pre-wired faceplate in-the-ear hearing aid models:
SP-W "A1"
SP-W "K1"
SP-W "K4"
"G1"
"G3"
Common name: hearing aid pre-wired faceplate
Classification name: hearing aid
Substantial equivalence: The functions and design of the above-named devices are substantially equivalent to existing conventional devices installed in in-the-ear hearing aids currently available through commercial distribution, such as:
| 510(k) Number | Trade/Proprietary Name | Manufacturer |
| --- | --- | --- |
| K884871 | Resound In-The-Ear Hearing Enhancement System | Resound Corp. |
| (Attachment 3) | | |
| K902846 | PRIZM Hearing System | AudioScience, Inc. |
| (Attachment 4) | | |
Description: Descriptions of the device functions, scientific concepts, and physical and performance characteristics of the above-mentioned Intrastar models are set forth in Attachments 1 and 2.
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{1}
Use: Segi Hearing Aid Co. is introducing into commercial distribution the above-mentioned Intrastar models of in-the-ear hearing aid pre-wired faceplates. The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing. Their function and design are substantially equivalent to those installed in existing conventional in-the-ear hearing aids currently available through commercial distribution.
Comparison of technological characteristics:
| | Intrastar
All models | Resound
K884871 | AudioScience
K902846 |
| --- | --- | --- | --- |
| Maximum SSPL90 | 124.8-133.2 dB | 114 dB SPL | 122 dB SPL |
| HF Avg. | 119.6-126.4 dB | 112 dB SPL | 114 dB SPL |
| Full on gain | 38.3-55.4 dB | 54 dB max | 54 dB |
| Reference test
gain | 38.3-49.4 dB | | 54 dB |
| Frequency range | 200-8000 Hz | 200-7000 Hz | 100-6800 Hz |
| THD 500 Hz | 1.6-5.2% | | <5% |
| THD 800 Hz | 1.8-13.4% | | <5% |
| THD 1600 Hz | 0.3-7.7% | | <5% |
| Equivalent input
noise | 19.0-29.4 dB | 28 dB SPL | 21-26 dB |
| Battery current | 0.74-1.37 mA | 1.3 mA | 2.2 mA |
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Panel 1
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