(197 days)
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.
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.
The provided text is a 510(k) summary for a pre-wired faceplate for in-the-ear hearing aids. It describes the device, its intended use, and compares its technical characteristics to two predicate devices. However, this document does not contain information about:
- Acceptance criteria in the context of a clinical study or performance evaluation.
- A specific study designed to prove the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are typically associated with studies evaluating diagnostic or AI-driven devices.
- Training set details.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technical specifications. Therefore, I cannot extract the requested information.
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<961593
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 HearingEnhancement 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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Segi Hearing Aid Co. is introducing into commercial Use: distribution the above-mentioned Intrastar models of in-theear 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:
| IntrastarAll models | ResoundK884871 | AudioScienceK902846 | |
|---|---|---|---|
| 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 testgain | 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 inputnoise | 19.0-29.4 dB | 28 dB SPL | 21-26 dB |
| Battery current | 0.74-1.37 mA | 1.3 mA | 2.2 mA |
§ 874.3300 Air-conduction hearing aid.
(a)
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.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.