Cochlear Implantation for Treatment of Single-sided Deafness

Not Applicable

Terminated

Conditions: Total Unilateral Deafness
Unilateral Partial Deafness

Interventions: Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

Registration Number: NCT02532972

Lead Sponsor: Dr. Daniel Lee

Brief Summary: 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).

Detailed Description: The goal of this study is to further investigate the role of CI in treating unilateral hearing loss and associated tinnitus. Single-sided deafness (SSD) afflicts approximately 60,000 new patients per year in the United States. The most common causes of these single-sided losses are sudden sensorineural hearing loss, Meniere's disease, trauma, and vestibular schwannoma. Patients with SSD face significant difficulty with communicating in the presence of background noise and in sound localization. Another significant problem for some SSD patients is tinnitus, which can be incapacitating and for which there are no therapies available that are considered to be of sufficient reliability to become a standard of care. Difficulty hearing in background noise and increased tinnitus can lead to significant frustration in social situations and contribute to increased isolation and a decreased quality of life. Treatment options for single sided deafness in the United States include contralateral routing of signals (CROS) hearing aids, bone-anchored hearing aids (BAHA) and use of assistive devices to improve the signal-to-noise in group situations. The first two devices take sound from the affected ear and transmit it to the unaffected ear. The last device consists of having a speaker wear a microphone and routing the signal directly to the patient's ear at a louder listening level. Although these devices can improve speech understanding in some patients, studies have shown that use of these devices does not ameliorate tinnitus or sound localization difficulties. Recent European studies have demonstrated that cochlear implantation (CI) can provide significant improvements in both perceived hearing ability and measured speech comprehension and localization in adult and pediatric patients with unilateral hearing loss. This suggests that CI may be a more effective option for this patient population than the CROS, BAHA or assistive devices.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cochlear Implant surgery	Med-el MAESTRO Cochlear Implant with Flex 28 electrode array	All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array

Primary Outcome Measures

Name	Time	Method
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing	Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively	Ability to recognize words and sentences read by the tester from a set list at a loudness of 65 dB HL. The outcome is measured as a percent score of words recognized. The test takes place in a quiet environment.
Sound Detection Via Pure-tone Threshold Audiometry (PTA)	3, 6 and 12 months post-operatively	Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB HL (decibels hearing level) where a lower number means more sensitive hearing and a higher number means less sensitive hearing.

Secondary Outcome Measures

Name	Time	Method
Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)	Preop and 12 months post-operatively	Tinnitus severity rated by the Tinnitus Handicap Index (THI). The THI score of 0-16 means "no or slight handicap", 18 to 36 indicates "mild", 38 to 56 indicates "moderate", 58 to 76 indicates "severe", and a score of 78-100 is classified as "catastrophic handicap"