FDA Device Intelligence
HomeHearing Assist II, Inc. › Hearing Assist

Hearing Assist

Hearing Assist II, Inc. · Model CONNECT · UDI-DI 00850007148935

QUG
0
510(k) clearances
13
Adverse events
1
Recalls
90
Facilities

Description

The Hearing Assist CONNECT is an air-conduction hearing aid with Bluetooth adjustment of acoustic parameters and audio streaming for phone and music.

Recalls

DateFirmReason
2025-04-25HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manu

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.