Hi Sonic 2000 Digital Hearing Instrument

FDA 510(k) K951678 · Hearing Innovations, Inc.

Substantially Equivalent

510(k) numberK951678

Submission

Device name
Hi Sonic 2000 Digital Hearing Instrument
Applicant
Hearing Innovations, Inc.
Washington, D.C., DC, US
Received
April 11, 1995
Decision date
June 7, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LXB – Hearing Aid, Bone Conduction
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3302
Specialty
Ear, Nose, Throat

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K254296Ossiclear (Ossiclear System)LXB · Traditional Sounduct07/22/2026SE
K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…LXB · Traditional Zdeer Technology (Henan) Co., Ltd.06/15/2026SE
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K211640Ponto 5 MiniLXB · Special Oticon Medical AB08/10/2021SE
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Questions and answers

When was Hi Sonic 2000 Digital Hearing Instrument cleared by the FDA?

Hi Sonic 2000 Digital Hearing Instrument (K951678) received a 510(k) decision of Substantially Equivalent on June 7, 1995, 57 days after the submission was received.

What is the product code of K951678?

The FDA product code is LXB – Hearing Aid, Bone Conduction, a Class II (moderate risk) device regulated under 21 CFR 874.3302.