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FDA Regulations and Cochlear Implantation for Unilateral Deafness

Patricia Trautwein, Ph.D

May 14, 2007



My son lost his hearing in one ear due to a motorcycle accident, the hearing is completely gone in one ear. He still has normal hearing in his other ear. Is there any technology that can be used to restore hearing in one dead ear? I see that Cochlear im


You are on the right track! Cochlear implants are currently approved for persons with bilateral severe to profound hearing loss. To date, there are very limited case reports from independent studies with the implantation of persons with unilateral deafness or a mild to moderately severe hearing loss opposite an ear that qualified for a cochlear implant. Given that the two forms of sound stimulation are very different as you indicate, further research is needed to investigate the feasibility of any clinical application for cochlear implants in persons with unilateral deafness. The current candidacy criteria as approved by the FDA does indicate bilateral severe or greater hearing loss.

For more information on Advanced Bionics, visit www.bionicear.com

Dr. Patricia Trautwein received her Masters Degree in Audiology from the State University of New York (SUNY) at Buffalo and her Doctorate of Audiology from the University of Florida. Patricia worked for several years as a research associate at the SUNY's Center for Hearing and Deafness Research. She joined the House Ear Institute as a pediatric audiologist where she was actively engaged in diagnostics, amplification, cochlear implants and research. Currently, Patricia is the Manager of Auditory Education and Training at Advanced Bionics Corporation. Patricia has authored and co-authored several publications on auditory hair cell regeneration, auditory plasticity and cochlear implantation.

patricia trautwein

Patricia Trautwein, Ph.D