Cochlear Implant Single Sided Deafness


Cochlear Implantation for Treatment of Single-sided Deafness

MEEI Protocol ID


National Clinical Trial (NCT) Number



Patients with partial or total deafness in one ear (and good hearing in the other ear)



Principal Investigator

Daniel J. Lee, M.D., FACS

Study Design

This is a safety and efficacy study of cochlear implantation (CI) for patients with single sided deafness.  All portions of the study occur at Massachusetts Eye and Ear, with the exception of some hearing testing performed at the University of Wisconsin before and after CI.

Study Objective

This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).

Who is Eligible

Inclusion Criteria:

  • Males and females 18 years of age or older with the ability to provide informed consent
  • Single Sided deafness for more than one year, with good hearing in the other ear
  • Expected subjects include those with:

-       Unilateral hearing loss secondary to viral or bacterial infection, such as meningitis or labyrinthitis

-       Ménière's disease

-       Sudden sensorineural hearing loss

-       Vascular disease affecting the inner ear

  • English as the primary language
  • Willing to receive/have received meningitis vaccinations
  • Unsuccessful trial of hearing amplification devices or tinnitus treatment for six months
  • Able to pay for cost of cochlear implant device maintenance, and able to comply with study requirements, including travel to the investigational sites
  • Tinnitus localized to the affected ear, both ears, or in the head localized to the affected ear, both ears, or in the head

Exclusion Criteria

  • Patients who have had single sided deafness for more than 10 years, have hearing loss in the good ear, have chronic ear infections or other chronic conditions in either ear, or are pregnant.

Subject Enrollment

Estimated 10

Study Procedures

Subjects will undergo a full hearing loss workup with testing performed at Mass Eye and Ear and the University of Wisconsin.  Subjects will be implanted with the cochlear implant in the deaf ear.  Subjects will undergo activation and attend multiple follow-up study visits for one year, including one trip to the University of Wisconsin.

For More Information; 617-573-3130