Stimulator, Auditory, Evoked Response

Reports per year

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-12-18Open, ClassifiedComponent change control

  MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

  Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.

• 2010-08-03TerminatedPMA

  SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154

  There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.

• 2010-05-27TerminatedDevice Design

  Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016

  This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions

• TerminatedDevice Design

  The ICS CHARTR EP 200

  There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.