Cochlear Implantation for Treatment of Single-sided Deafness
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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"
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Dr. Daniel Lee
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Daniel J Lee, MD, FACS, MEEI / MGH
Study Documents (Full-Text)
More Information
Publications
- Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.
- Arts RA, George EL, Stokroos RJ, Vermeire K. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):398-403. doi: 10.1097/MOO.0b013e3283577b66. Review.
- Bishop CE, Eby TL. The current status of audiologic rehabilitation for profound unilateral sensorineural hearing loss. Laryngoscope. 2010 Mar;120(3):552-6. doi: 10.1002/lary.20735. Review.
- Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.
- Kamal SM, Robinson AD, Diaz RC. Cochlear implantation in single-sided deafness for enhancement of sound localization and speech perception. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):393-7. doi: 10.1097/MOO.0b013e328357a613. Review.
- Linstrom CJ, Silverman CA, Yu GP. Efficacy of the bone-anchored hearing aid for single-sided deafness. Laryngoscope. 2009 Apr;119(4):713-20. doi: 10.1002/lary.20164.
- Litovsky R, Parkinson A, Arcaroli J, Sammeth C. Simultaneous bilateral cochlear implantation in adults: a multicenter clinical study. Ear Hear. 2006 Dec;27(6):714-31.
- Litovsky RY, Parkinson A, Arcaroli J. Spatial hearing and speech intelligibility in bilateral cochlear implant users. Ear Hear. 2009 Aug;30(4):419-31. doi: 10.1097/AUD.0b013e3181a165be.
- Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8.
- Noble W, Gatehouse S. Effects of bilateral versus unilateral hearing aid fitting on abilities measured by the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Int J Audiol. 2006 Mar;45(3):172-81.
- Popelka GR, Derebery J, Blevins NH, Murray M, Moore BC, Sweetow RW, Wu B, Katsis M. Preliminary evaluation of a novel bone-conduction device for single-sided deafness. Otol Neurotol. 2010 Apr;31(3):492-7. doi: 10.1097/MAO.0b013e3181be6741.
- Punte AK, Vermeire K, Hofkens A, De Bodt M, De Ridder D, Van de Heyning P. Cochlear implantation as a durable tinnitus treatment in single-sided deafness. Cochlear Implants Int. 2011 May;12 Suppl 1:S26-9. doi: 10.1179/146701011X13001035752336.
- Ramos Á, Polo R, Masgoret E, Artiles O, Lisner I, Zaballos ML, Moreno C, Osorio Á. Cochlear implant in patients with sudden unilateral sensorineural hearing loss and associated tinnitus. Acta Otorrinolaringol Esp. 2012 Jan-Feb;63(1):15-20. doi: 10.1016/j.otorri.2011.07.004. Epub 2011 Nov 30. English, Spanish.
- Saroul N, Akkari M, Pavier Y, Gilain L, Mom T. Long-term benefit and sound localization in patients with single-sided deafness rehabilitated with an osseointegrated bone-conduction device. Otol Neurotol. 2013 Jan;34(1):111-4. doi: 10.1097/MAO.0b013e31827a2020. Erratum in: Otol Neurotol. 2013 Jul;34(5):970. Nicolas, Saroul [corrected to Saroul, Nicolas]; Mohamed, Akkari [corrected to Akkari, Mohamed]; Yoann, Pavier [corrected to Pavier, Yoann]; Laurent, Gilain [corrected to Gilain, Laurent]; Thierry, Mom [corrected to Mom, Thierry].
- Snapp H, Angeli S, Telischi FF, Fabry D. Postoperative validation of bone-anchored implants in the single-sided deafness population. Otol Neurotol. 2012 Apr;33(3):291-6. doi: 10.1097/MAO.0b013e3182429512.
- Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52.
- Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.
- 13-054H
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cochlear Implant Surgery |
|---|---|
| Arm/Group Description | All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array 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. |
| Period Title: Overall Study | |
| STARTED | 11 |
| COMPLETED | 10 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Cochlear Implant Surgery |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 11 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
7
63.6%
|
| >=65 years |
4
36.4%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
54
|
| Sex: Female, Male (Count of Participants) | |
| Female |
8
72.7%
|
| Male |
3
27.3%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (Count of Participants) | |
| United States |
11
100%
|
| Sound detection via pure-tone air conduction threshold audiometry (dB) [Mean (Full Range) ] | |
| Better Ear |
13.1
|
| Worse Ear |
96.25
|
Outcome Measures
| Title | Sound Detection Via Pure-tone Threshold Audiometry (PTA) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Cochlear Implant Surgery |
|---|---|
| Arm/Group Description | All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array 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. |
| Measure Participants | 11 |
| 3 months post-operative |
42.36
|
| 6 months post-operative |
45.13
|
| 12 months post-operative |
39.58
|
| Title | Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Cochlear Implant Surgery |
|---|---|
| Arm/Group Description | All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array 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. |
| Measure Participants | 11 |
| Pre-operative |
4
|
| 1-4 weeks post-surgery |
16
|
| 3 months post-surgery |
42
|
| 6 months post-surgery |
40
|
| 12 months post-surgery |
46
|
| Title | Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Cochlear Implant Surgery |
|---|---|
| Arm/Group Description | All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array 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. |
| Measure Participants | 11 |
| Pre-operative |
56.2
|
| 12 months post-surgery |
6.8
|
Adverse Events
| Time Frame | 1 year following surgery | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Cochlear Implant Surgery | |
| Arm/Group Description | Med-El MAESTRO Cochlear Implant with Flex 28 electrode array | |
All Cause Mortality |
||
| Cochlear Implant Surgery | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Serious Adverse Events |
||
| Cochlear Implant Surgery | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/11 (18.2%) | |
| Musculoskeletal and connective tissue disorders | ||
| hip replacement | 1/11 (9.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| pneumonia | 1/11 (9.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Cochlear Implant Surgery | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/11 (81.8%) | |
| Blood and lymphatic system disorders | ||
| bleeding at surgical site | 1/11 (9.1%) | 1 |
| Ear and labyrinth disorders | ||
| otitis media | 1/11 (9.1%) | 1 |
| tinnitus | 2/11 (18.2%) | 2 |
| vertigo | 1/11 (9.1%) | 1 |
| eardrum perforation | 1/11 (9.1%) | 1 |
| hyperacusis in non-implanted ear | 1/11 (9.1%) | 1 |
| general otalgia and otorrhea, intermittent | 1/11 (9.1%) | 1 |
| Gastrointestinal disorders | ||
| nausea and vomiting | 1/11 (9.1%) | 2 |
| General disorders | ||
| taste disturbance | 3/11 (27.3%) | 4 |
| oral dryness | 1/11 (9.1%) | 1 |
| Product Issues | ||
| magnet retention issues requiring stronger magnet | 1/11 (9.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| dermatitis (eyelid) | 1/11 (9.1%) | 1 |
| postauricular irritation | 1/11 (9.1%) | 2 |
| incision tenderness/irritation | 3/11 (27.3%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Daniel Lee |
|---|---|
| Organization | Massachusetts Eye & Ear Infirmary |
| Phone | 6175736981 |
| Daniel_Lee@meei.harvard.edu |
- 13-054H