Total Unilateral DeafnessNCT02532972

Cochlear Implantation for Treatment of Single-sided Deafness

A study testing Med-el MAESTRO Cochlear Implant with Flex 28 electrode array in people with Total Unilateral Deafness and Unilateral Partial Deafness, run by Dr. Daniel Lee at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Unilateral Deafness, Unilateral Partial Deafness
What is being tested?: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Sep 2015to 25 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 15Show fewer

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

Who cannot join

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)

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114

Other trials in United States

About this study

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).

Read the 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.

Conditions: Total Unilateral Deafness, Unilateral Partial Deafness
Being tested: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Med-el MAESTRO Cochlear Implant with Flex 28 electrode arrayDevice
Also called CI, cochlear implant
Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.

Study groups in NCT02532972
Study group	Role	What they receive
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 Receives: Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
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"
Measured: Preop and 12 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201525 Apr 2019

First posted26 Aug 2015 (estimated)
Study startSep 2015
Primary completion27 Feb 2019
Study completion25 Apr 2019

Why it stopped: Closed by IRB

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Total Unilateral DeafnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02532972
Sponsor's protocol ID: 13-054H
Status last verified: Apr 2020
First submitted: 14 Aug 2015
Last updated: 5 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 21068690
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.
PubMed 22931903
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.
PubMed 20014322
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.
PubMed 22935813
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.
PubMed 22886035
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.
PubMed 21756468
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.
PubMed 19266579
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.
PubMed 17086081
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.
PubMed 19455039
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.
PubMed 23202156
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.
PubMed 12544032
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.
PubMed 16579492
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.
PubMed 19816229
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.
PubMed 22136970
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.
PubMed 22314919

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cochlear Implantation for Treatment of Single-sided Deafness
ClinicalTrials.gov ID: NCT02532972
Acronym / sponsor ID: 13-054H
Conditions: Total Unilateral Deafness, Unilateral Partial Deafness
Study type: Interventional
Recruitment status: TerminatedReason stopped: Closed by IRB
Enrolment: 11 participants (actual)
Lead sponsor: Dr. Daniel LeeUniversity, hospital or other
Collaborators: University of Wisconsin, Madison
Study start: Sep 2015 (actual)
Primary completion: 27 Feb 2019 (actual)
Study completion: 25 Apr 2019 (actual)
First posted: 26 Aug 2015 (estimated)
Results: Posted 11 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cochlear Implant surgery	Experimental	Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode arrayAll subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Med-el MAESTRO Cochlear Implant with Flex 28 electrode arrayAlso: CI, cochlear implantCochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.	Device	Cochlear Implant surgery

Primary outcome

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.
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.

1 secondary outcome

Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)
Time frame: Preop and 12 months post-operatively

Results and safety

Results posted to the registry on 11 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cochlear Implant Surgery	11	10

Primary outcome: Sound Detection Via Pure-tone Threshold Audiometry (PTA)

Time frame: 3, 6 and 12 months post-operatively. Mean (Full Range). Unit: dB HL

Measure	Cochlear Implant Surgery n = 11
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)

Population analysed: 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.

Primary outcome: 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. Mean (Full Range). Unit: percentage of words recognized

Measure	Cochlear Implant Surgery n = 11
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)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year following surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cochlear Implant Surgery	2 of 11 (18.2%)	9 of 11 (81.8%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21068690Arndt 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.
Background: PubMed 22931903Arts 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.
Background: PubMed 20014322Bishop 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.
Background: PubMed 22935813Firszt 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.
Background: PubMed 22886035Kamal 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.
Background: PubMed 21756468Punte 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.
Background: PubMed 19266579Linstrom 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.
Background: PubMed 17086081Litovsky 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.
Background: PubMed 19455039Litovsky 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.
Background: PubMed 23202156Saroul 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.
Background: PubMed 12544032Niparko 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.
Background: PubMed 16579492Noble 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J Lee, MD, FACS principal investigator

MEEI / MGH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sound Detection Via Pure-tone Threshold Audiometry (PTA) (time frame: 3, 6 and 12 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02532972, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.