Cochlear Implantation for Treatment of Single-sided Deafness

NCT02532972 | Terminated Results FDA Device

• 1 other identifier: 13-054H
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Total Unilateral Deafness; Unilateral Partial Deafness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively

Secondary Outcomes (1)

• Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)

  Preop and 12 months post-operatively

Study Arms (1)

Cochlear Implant surgery

EXPERIMENTAL

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

Interventions

Med-el MAESTRO Cochlear Implant with Flex 28 electrode array DEVICE

Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.

Also known as: CI, cochlear implant

Cochlear Implant surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Daniel Lee: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (18)

• 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.

  PMID: 21068690 BACKGROUND

• 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.

  PMID: 22931903 BACKGROUND

• 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.

  PMID: 20014322 BACKGROUND

• 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.

  PMID: 22935813 BACKGROUND

• 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.

  PMID: 22886035 BACKGROUND

• 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.

  PMID: 21756468 BACKGROUND

• 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.

  PMID: 19266579 BACKGROUND

• 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.

  PMID: 17086081 BACKGROUND

• 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.

  PMID: 19455039 BACKGROUND

• 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.

  PMID: 23202156 BACKGROUND

• 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.

  PMID: 12544032 BACKGROUND

• 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.

  PMID: 16579492 BACKGROUND

• 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.

  PMID: 19816229 BACKGROUND

• 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.

  PMID: 22136970 BACKGROUND

• 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.

  PMID: 22314919 BACKGROUND

• 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.

  PMID: 18834065 BACKGROUND

• 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.

  PMID: 19005250 BACKGROUND

• Thakkar T, Knoepker J, Dennison SR, Roche JP, Litovsky RY. Spatial separation enhances speech intelligibility but increases listening effort with session-dependent variability in pupillometric measures. Front Neurosci. 2025 Nov 10;19:1655826. doi: 10.3389/fnins.2025.1655826. eCollection 2025.

  PMID: 41333071 DERIVED

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: Dr. Daniel Lee
• Organization: Massachusetts Eye & Ear Infirmary

Daniel_Lee@meei.harvard.edu

6175736981

Study Officials

• Daniel J Lee, MD, FACS

  MEEI / MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pediatric Otology and Neurotology

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 26, 2015
• Study Start: September 1, 2015
• Primary Completion: February 27, 2019
• Study Completion: April 25, 2019
• Last Updated: May 5, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)