Cochlear Implantation for Treatment of Single-sided Deafness

Stopped early · Not applicable

Conditions studied: Total Unilateral Deafness, Unilateral Partial Deafness

In brief

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).

Key facts

Study ID

NCT02532972

Run by

Dr. Daniel Lee

People needed

11

Starts

2015-09-01

Expected to finish

2019-04-25

Last updated by the study team

2020-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older with the ability to provide informed consent
• English as the primary language
• Medically and psychologically suitable
• Willing to receive/have received meningitis vaccinations
• Able to pay for all care received through the study, either through the subject's insurance company or through self-pay
• Able to comply with study requirements, including travel to the investigational sites
• Severe to profound sensorineural hearing loss (≥70 dB HL (decibel hearing level) thresholds between 500 and 4000 Hz) in the worse ear with ≤ 20% Consonant-Nucleus-Consonant (CNC) word scores
• Duration of single-sided deafness ≥ one year
• Tinnitus localized to the affected ear, both ears, or in the head localized to the affected ear, both ears, or in the head
• 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
• A combination of any number of the above conditions

You may not qualify if…

• Duration of single-sided deafness ≥ ten years
• Pure tone thresholds ≥ 35 dB HL at 500, 1000, 2000, and 4000 Hz in the better ear
• Consonant-Nucleus-Consonant (CNC) word scores ≤ 70% in the better ear
• Chronic otitis media in either ear
• Inner ear malformation in either ear
• Autoimmune inner ear disease (fluctuation sensorineural hearing loss in either ear)
• Evidence of retrocochlear pathology, including vestibular schwannoma
• Unilateral tinnitus in the unaffected ear
• Cochlear ossification
• Demonstrated cognitive and/or developmental challenges
• Major depression or anxiety; post-traumatic stress disorder; substance abuse
• Medical or psychological conditions that serve as contraindication to surgery
• Additional handicaps that would prevent or limit participation in evaluations
• Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
• Pregnant women: The investigators will specifically ask all women of childbearing age if there is a possibility they are pregnant or trying to become pregnant at the initial clinic visit; any women who are pregnant or actively trying to become pregnant will be excluded. In cases that are questionable on the day of planned surgery, a pregnancy test will be performed as per current Massachusetts Eye \& Ear Infirmary anesthesia pre-operative protocols.

Where it is running

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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