HI SONIC 2000 DIGITAL HEARING INSTRUMENT— 510(k) K951678

Substantially Equivalent

Hearing Innovations, Inc.

FDA 510(k) clearance K951678 for HI SONIC 2000 DIGITAL HEARING INSTRUMENT, Substantially Equivalent on 1995-06-07. Applicant: Hearing Innovations, Inc..

Clearance details

Applicant: Hearing Innovations, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 1995-04-11
Decision date: 1995-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.