510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951678Substantially Equivalent

Hi Sonic 2000 Digital Hearing Instrument

Hearing Innovations, Inc., Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951678 is the FDA 510(k) clearance record for HI SONIC 2000 DIGITAL HEARING INSTRUMENT, a class II device, cleared for Hearing Innovations, Inc. on under FDA product code LXB (Hearing Aid, Bone Conduction). FDA records list 3 510(k) clearances for Hearing Innovations, Inc., from to . As of , FDA records show no recalls naming K951678.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LXB Hearing Aid, Bone Conduction
Regulation
21 CFR 874.3302
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Hearing Innovations, Inc. Columbia Sq., Washington, D.C. DC
510(k) summary
Summary
Third party review
No

Clearances, product code LXB

Trailing 12 months
4 clearances under product code LXB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LXB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20261
September 20260
October 20260