Cochlear Implantation for Treatment of Single-sided Deafness

• ClinicalTrials.gov Identifier: NCT02532972
• Recruitment Status: Terminated
• First Posted: August 26, 2015
• Results First Posted: March 11, 2020
• Last Update Posted: May 5, 2020
• Sponsor: Dr. Daniel Lee
• Collaborator: University of Wisconsin, Madison
• Information provided by (Responsible Party): Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary

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
Total Unilateral Deafness; Unilateral Partial Deafness	Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cochlear Implantation for Treatment of Single-sided Deafness
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: February 27, 2019
• Actual Study Completion Date: April 25, 2019

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: CI; cochlear implant

Outcome Measures

Primary Outcome Measures :

1. Sound Detection Via Pure-tone Threshold Audiometry (PTA) [ Time Frame: 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.
2. Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing [ Time Frame: 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 :

1. Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI) [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

United States, Massachusetts

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)

Documents provided by Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary:

Study Protocol and Statistical Analysis Plan  [PDF] August 17, 2015

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.

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.

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.

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.

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. doi: 10.1097/01.aud.0000246816.50820.42.

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.

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].

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. doi: 10.1097/00129492-200301000-00015.

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. doi: 10.1080/14992020500376933.

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.

Ramos A, Polo R, Masgoret E, Artiles O, Lisner I, Zaballos ML, Moreno C, Osorio A. 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.

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. doi: 10.1177/000348940811700903.

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.

• Responsible Party: Dr. Daniel Lee, Director, Pediatric Otology and Neurotology, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT02532972
• Other Study ID Numbers: 13-054H
• First Posted: August 26, 2015
• Results First Posted: March 11, 2020
• Last Update Posted: May 5, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Deafness; Hearing Loss; Hearing Loss, Unilateral; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases