Auditory Efficacy and Safety Services from CBSET & Cilcare

CBSET and hearing specialists, Cilcare, have created a strategic alliance to offer a broad range of cutting-edge preclinical services for the assessment of drugs, medical devices, and gene and cell-based therapies for auditory functions in a GLP-compliant environment.

6 Years of Partnership Milestones

Since partnering with Cilcare, we have conducted numerous GLP and non-GLP safety and efficacy studies on a wide range of hearing therapies.

One of these therapies, designed to provide durable restoration of hearing to individuals born with profound hearing loss due to a genetic mutation, recently gained FDA approval for clinical trials.

Extensive History in Otology Research

With expertise in both GLP and non-GLP otology research, we provide a broad range of in vivo models, enabling studies from proof-of-concept and non-GLP programs through fully GLP-compliant safety assessments. Inner ear and systemic pharmacokinetics, ototoxicity, and safety and efficacy studies may be conducted in a variety of preclinical species and models including device-mediated therapy (such as cochlear implants and implantable drug delivery systems), biologics and therapeutic proteins, small molecules, cell products, or gene therapy vectors, all in accordance with best practices and applicable regulatory guidelines.

A Broad Range of Technical Capabilities for Auditory Therapy Assessment

Our technical capabilities include in-life assessment with high-throughput electrophysiological measurements and post-mortem assessments via immunohistochemistry, histopathology, and hair cell and ribbon synapse quantification. In addition, our otic research scientists and surgeons can provide method development support to adapt or replicate challenging technical procedures including cochleostomy, canalostomy, and round window injections targeting different sites of interest.

  • Expertise in auditory assessment
    • ABR (Auditory Brainstem Response) measurements
    • Otoscopic evaluation
    • Tympanometry
    • Cytocochleogram
    • Ribbon synapses counting
    • Histopathology and immunohistochemistry
    • Imaging
    • Cochlear explants
  • Animal models
    • Drug-induced ototoxicity
    • Otitis media
  • Animal species
    • Rodents
    • Guinea pigs
    • Chinchilla
    • Swine
    • Sheep
  • Routes of delivery
    • Transtympanic
    • Round window
    • Intracochlear
    • Intrabullar
  • Samplings
    • Perilymph & cochlea
    • Tympanic bulla
    • CSF and other tissues

abrgraphic

ABR are electric potentials recorded from scalp electrodes. This non-invasive method allows determination of auditory response thresholds. It is translational between rodents and humans, and is commonly used for screening newborns.

cytocochleogramimage

The cytocochlelogram allows histopathological assessment of ototoxic damage on inner hair cell and outer hair cell of the cochlea, with anatomical localization corresponding to predicable patterns of functional deficits.

CBSET Partner Cilcare wins French-American Chamber of Commerce of New England (FACCNE) Award in the "Women in Business" Category

Watch: Peter S. Steyger of Creighton University and CBSET's Rami Tzafriri host workshop on Translational Delivery Approaches for Inner Ear Therapies.

Watch: Peter Markham & Celia Belline discuss New Medical Approaches to Treating Hearing Loss in Hearing Health Matters interview.

Watch: CILcare-CBSET receive Hearing Innovator Award in Therapeutics

Watch: Mathieu Schue, PhD, CILcare’s Project Director in Drug Development and Translational Research, presents on chronic inflammatory diseases and hearing loss

Watch: CBSET's John Keating presents In Vivo Models to Assess Ototoxicity

Watch: HEARING MATTERS - What Can You Do To Prevent Ototoxicity?

Watch: A focus on new treatments for hearing loss.