Auditory Safety Testing

With more than 15 years of experience in auditory safety testing, our team has become the go-to lab for evaluating the potential ototoxicity of a compound. Drugs administered into the middle ear (or those which contact the middle and inner ear tissues), as well as drug classes that have demonstrated ototoxicity following systemic administration (e.g., aminoglycoside, antibiotics, sildenafil) should be subject to a thorough safety evaluation that includes functional auditory testing and relevant histopathology to assess possible ototoxicity. Based on regulatory guidance, we perform functional auditory testing, test relevant histopathology, and evaluate the cytocochleogram to assess potential ototoxicity of a compound. These assessments provide data to support the safety of these compounds. We collaborate with sponsors and regulatory experts to develop the best program to determine if the drug is ready for further clinical evaluation for these specific indications.

Learn more about our comprehensive approach to auditory safety assessment (PDF available through The Source℠).

Ototoxicity Capabilities

  • ABR electrophysiology
  • Distortion product otoacoustic emissions (DPOAE)
  • Middle ear assessment
  • Definitive histopathological evaluations of the cochlea
  • Cytocochleogram
  • Specialized clinical observations to recognize vestibular/ototoxicant changes
  • Surgical, oral, and parenteral administrations

Ototoxicity Models 

  • Evaluation of compounds for potential ototoxicity
  • Drug-induced hearing loss
  • Drug-induced vestibular loss
  • Distribution of compounds in specialized tissues/compartments
  • Inner ear immunohistochemistry

Ototoxicity Endpoints

  • Drug distribution
  • Auditory brainstem response evaluation
  • Otic histopathology and microscopy
  • Auditory hair cell analysis and cytocochleogram
  • Vestibular organ analysis and histomorphometry