Total Unilateral Deafness, Unilateral Partial Deafness
Conditions
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.
Interventions
DEVICEMed-el MAESTRO Cochlear Implant with Flex 28 electrode array
Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Sponsors
University of Wisconsin, Madison
Dr. Daniel Lee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cochlear Implant Surgery All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array. Intervention consists of Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cochlear Implant Surgery | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 54 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
| Sound detection via pure-tone air conduction threshold audiometry Better Ear | 13.1 dB | — |
| Sound detection via pure-tone air conduction threshold audiometry Worse Ear | 96.25 dB | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 9 / 11 |
| serious Total, serious adverse events | 2 / 11 |
Outcome results
Primary
Sound Detection Via Pure-tone Threshold Audiometry (PTA)
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.
Time frame: 3, 6 and 12 months post-operatively
Population: 11 participants had surgery, but one subject opted out of additional follow-up after the 6 month visit one subject did not return for his one year followup visit following activation. As such,12 month time points only have 9 participants' data analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant Surgery | Sound Detection Via Pure-tone Threshold Audiometry (PTA) | 3 months post-operative | 42.36 dB HL |
| Cochlear Implant Surgery | Sound Detection Via Pure-tone Threshold Audiometry (PTA) | 6 months post-operative | 45.13 dB HL |
| Cochlear Implant Surgery | Sound Detection Via Pure-tone Threshold Audiometry (PTA) | 12 months post-operative | 39.58 dB HL |
Primary
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
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.
Time frame: Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively
Population: 11 participants had surgery, but one subject opted out of additional follow-up after the 6 month visit one subject did not return for his one year followup visit following activation. As such,12 month time points only have 9 participants' data analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant Surgery | Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Pre-operative | 4 percentage of words recognized |
| Cochlear Implant Surgery | Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | 1-4 weeks post-surgery | 16 percentage of words recognized |
| Cochlear Implant Surgery | Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | 3 months post-surgery | 42 percentage of words recognized |
| Cochlear Implant Surgery | Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | 6 months post-surgery | 40 percentage of words recognized |
| Cochlear Implant Surgery | Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | 12 months post-surgery | 46 percentage of words recognized |
Secondary
Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)
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
Time frame: Preop and 12 months post-operatively
Population: 11 participants had surgery, pre and postoperative 12 month time points have 5 participants with available Tinnitus Handicap Index (THI) data 1/11 - did not have THI data available preoperatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant Surgery | Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI) | Pre-operative | 56.2 score on a scale |
| Cochlear Implant Surgery | Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI) | 12 months post-surgery | 6.8 score on a scale |