An interventional study of Med-el MAESTRO Cochlear Implant with Flex 28 electrode array in Total Unilateral Deafness and Unilateral Partial Deafness, sponsored by Dr. Daniel Lee. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Dr. Daniel Lee · Not applicable, Interventional, and Treatment
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).
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.
609 studies on the registry are indexed under Deafness; 111 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 411 interventional studies indexed under Deafness.
Browse Deafness studies →This is the only study on the registry with Dr. Daniel Lee as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array
Device: Med-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.
Also known as: CI, cochlear implant
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
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
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
| Milestone | Cochlear Implant Surgery |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| dB HL | Cochlear Implant Surgery |
|---|---|
| 3 months post-operative | 42.36 (31.25 to 47.5) |
| 6 months post-operative | 45.13 (33.75 to 66.25) |
| 12 months post-operative | 39.58 (35 to 46.25) |
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.
| percentage of words recognized | Cochlear Implant Surgery |
|---|---|
| Pre-operative | 4 (0 to 26) |
| 1-4 weeks post-surgery | 16 (0 to 34) |
| 3 months post-surgery | 42 (10 to 64) |
| 6 months post-surgery | 40 (4 to 72) |
| 12 months post-surgery | 46 (8 to 72) |
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"
| score on a scale | Cochlear Implant Surgery |
|---|---|
| Pre-operative | 56.2 (6 to 96) |
| 12 months post-surgery | 6.8 (2 to 14) |
Collected over 1 year following surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cochlear Implant Surgery | 0/11 (0%) | 2/11 (18.2%) | 9/11 (81.8%) |
| Event | Cochlear Implant Surgery |
|---|---|
| pneumoniaRespiratory, thoracic and mediastinal disorders | 1/11 |
| hip replacementMusculoskeletal and connective tissue disorders | 1/11 |
| Event | Cochlear Implant Surgery |
|---|---|
| incision tenderness/irritationSkin and subcutaneous tissue disorders | 3/11 |
| taste disturbanceGeneral disorders | 3/11 |
| tinnitusEar and labyrinth disorders | 2/11 |
| dermatitis (eyelid)Skin and subcutaneous tissue disorders | 1/11 |
| postauricular irritationSkin and subcutaneous tissue disorders | 1/11 |
| otitis mediaEar and labyrinth disorders | 1/11 |
| vertigoEar and labyrinth disorders | 1/11 |
| nausea and vomitingGastrointestinal disorders | 1/11 |
| eardrum perforationEar and labyrinth disorders | 1/11 |
| bleeding at surgical siteBlood and lymphatic system disorders | 1/11 |
| Age, Categorical(Participants) | Cochlear Implant Surgery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 4 |
| Age, Continuous(years) | Cochlear Implant Surgery |
|---|---|
| Mean | 54 (26 to 77) |
| Sex: Female, Male(Participants) | Cochlear Implant Surgery |
|---|---|
| Female | 8 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Cochlear Implant Surgery |
|---|
| Region of Enrollment(Participants) | Cochlear Implant Surgery |
|---|---|
| United States | 11 |
| Sound detection via pure-tone air conduction threshold audiometry(dB) | Cochlear Implant Surgery |
|---|---|
| Better Ear | 13.1 (6 to 24) |
| Worse Ear | 96.25 (64 to 120) |
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