Cochlear Implantation in Cases of Single-Sided Deafness

NCT02203305 | Completed Results

• 1 other identifier: 14-1544
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Conditions

Unilateral Moderate to Profound Hearing Loss; Asymmetric Hearing Loss; Single-Sided Deafness (SSD)

Keywords

Unilateral hearing loss; Single Sided Deafness; Asymmetric hearing loss

Outcome Measures

Primary Outcomes (14)

• Change in Word Recognition in Quiet Over Time

  Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time

  Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time

  Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

  Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Localization Results (Measured in Variable Error) Over Time

  Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Localization Results (Measured in Constant Error) Over Time

  Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Localization Results (Measured in Adjusted Constant Error) Over Time

  Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time

  Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time

  Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

  Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front

  Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front

  Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

  Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

  Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Secondary Outcomes (16)

• Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)

  preoperative interval and 12 month post-activation interval

• Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

  preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)

• Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

  Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

• Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

  preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)

Other Outcomes (1)

• Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period

  post-activation period (1, 3, 6, and 12 months post-activation)

Study Arms (3)

Cochlear Implant

EXPERIMENTAL

Cochlear implantation of the affected ear

Device: Cochlear Implant

Control Group

OTHER

A control group without the study intervention (cochlear implantation) will complete the test battery.

Other: Control Group

Cochlear Implant: Asymmetric hearing loss

EXPERIMENTAL

Cochlear implantation of the poorer hearing ear

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss

Also known as: MED-EL CONCERT cochlear implant system, MED-EL SYNCHRONY cochlear implant system

Cochlear Implant; Cochlear Implant: Asymmetric hearing loss

Control Group OTHER

Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.

Also known as: bone-conduction device

Control Group

Eligibility Criteria

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

You may qualify if:

• Unilateral moderate-to-profound sensorineural hearing loss \[Unaided residual hearing thresholds measured from 250-8000 Hertz (Hz) (Pure Tone Average (PTA) ≥70 decibel (dB) Hearing Level (HL) in the ear to be implanted\]
• Normal to mild residual hearing thresholds from 250-8000 Hz in the contralateral ear (≤35 dB HL at each frequency, 250-8000 Hz)
• Greater than or equal to 18 years of age at implantation
• Duration of moderate-to-profound sensorineural hearing loss less than or equal to 5 years \[Either reported by subject or documented in previous audiograms\] \[Can be less than or equal to 10 years if the subject consistently utilized hearing technology (such as a bone conduction device or conventional hearing aid) within the past 5 years\]
• Previous experience with a current treatment option for SSD, including a conventional hearing aid, bone-conduction device, or CROS/BICROS (Bilateral Contralateral Routing Of the Signal) technology. \[At least one month of listening experience with device\] \[Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit\]
• Aided word recognition in the ear to be implanted of 60% or less as measured with Consonant-Nucleus-Consonant (CNC) words (50-word list) \[When listening with an appropriately fit hearing aid and masking applied to the contralateral ear\] \[Aided testing will be conducted in a sound-proof booth with the subject seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB Sound Pressure Level (SPL).\] \[The hearing aid output will be measured using National Acoustic Laboratory-NonLinear (NAL-NL1) targets.\]
• Realistic expectations
• Willing to obtain recommended meningitis vaccinations per Center for Disease Control (CDC) recommendations
• No reported cognitive issues \[Pass the Mini Mental State Examination (MMSE) screener\]
• Able and willing to comply with study requirements, including travel to investigational site and study-related activities

You may not qualify if:

• Non-native English speaker \[Speech perception materials are presented in English\]
• Conductive hearing loss in either ear
• Compromised auditory nerve, including those with a history of vestibular schwannoma
• Ossification
• Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
• History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia
• Meniere's disease with intractable vertigo
• Trauma that precludes inner ear surgery
• Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
• Pregnancy \[Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child.\] \[Subjects who become pregnant after surgery may continue to participate in study procedures\]
• Tinnitus as the primary purpose for seeking cochlear implantation
• Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson \& Spitzer, 1996).
• a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL iii. Aided word recognition of 60% or less as measured with CNC words (50-word list).
• b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as measured with CNC words (50-word list).
• iii. Use of conventional amplification c. Greater than or equal to 18 years of age at implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to be implanted is less than or equal to 5 years \[Either reported by subject or documented in previous audiograms. Can be up to 10 years if the subject consistently utilized hearing technology in the ear to be implanted (such as a bone conduction device or conventional hearing aid) within the past 5 years\] e. Previous experience with a current treatment option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction device, or CROS/BiCROS technology. \[At least one month of listening experience with device. Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit.\] f. Realistic expectations g. Willing to obtain recommended meningitis vaccinations per CDC recommendations h. No reported cognitive issues \[Pass the Mini Mental State Examination (MMSE) screener\] i. Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Med-El Corporation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (5)

• 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

• 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

• Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Meniere's disease. Otol Neurotol. 2013 Dec;34(9):1681-7. doi: 10.1097/MAO.0000000000000102.

  PMID: 24232066 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

• Dillon MT, Buss E, Anderson ML, King ER, Deres EJ, Buchman CA, Brown KD, Pillsbury HC. Cochlear Implantation in Cases of Unilateral Hearing Loss: Initial Localization Abilities. Ear Hear. 2017 Sep/Oct;38(5):611-619. doi: 10.1097/AUD.0000000000000430.

  PMID: 28375876 DERIVED

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Cochlear Implants; Control Groups

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

Unable to reach maximum enrollment in the control group (bone conduction device users).

Results Point of Contact

• Title: Dr. Margaret Dillon
• Organization: University of North Carolina at Chapel Hill

mdillon@med.unc.edu

9199665251

Study Officials

• Margaret Dillon, AuD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 29, 2014
• Study Start: October 1, 2014
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: July 25, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-02

Locations

US (1)