Clinical trial NCT02203305: Cochlear Implantation in Cases of Single-Sided Deafness
Official title: Cochlear Implantation in Cases of Single-Sided Deafness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Moderate to Profound Hearing Loss
Asymmetric Hearing Loss
Single-Sided Deafness (SSD)
Keywords: Unilateral hearing loss
Single Sided Deafness
Asymmetric hearing loss
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Med-El Corporation
First posted: 2014-07-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss with limited speech perception benefit in one ear and normal hearing in the contralateral ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech perception in noise, variable abilities on localization tasks, increased subjective report of hearing handicap, and reduced quality of life.

This patient population cannot utilize conventional amplification due to the severity of the hearing loss and poor speech discrimination abilities in the affected ear. Current treatment options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends the acoustic signal from the affected ear to the receiver, which is presented to the normal hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to send the acoustic signal from the affected side to the normal hearing ear via vibrations. The goal of both of these technologies is to send the signal from the affected side to the normal hearing side, thereby leaving the patient in a unilateral listening condition.

Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides to the better hearing ear, the ability to use binaural cues for speech perception in noise is variable.

It is of interest whether cochlear implantation of the affected ear would benefit the SSD population. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically implanted into the affected cochlea. The external speech processor receives sounds and transmits this signal to the internal portion. The electrode array presents the acoustic signal via electrical pulses within the cochlea, which is interpreted by the brain as sound.

Presumably, cochlear implantation may provide the SSD population improvements in speech perception in the affected ear, which cannot benefit from appropriately fit hearing aids. Cochlear implantation may provide a benefit over current treatment options in the SSD population, as it stimulates the auditory pathway on the affected side, thus allowing for ipsilateral representation of acoustic signals arriving to each ear independently.

The primary goal of this project is to determine whether subjects with SSD experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition. Secondary aims include: 1) a comparison of speech perception, localization, and quality of life outcomes in the study population to a SSD control group with long-term listening experience with a current treatment option (i.e. bone-conduction device), and 2) a within-subject comparison of speech perception and localization abilities with cochlear implantation versus the bone-conduction test device.

Eligibility criteria: Inclusion Criteria (SSD):

* 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

Exclusion Criteria (SSD):

* 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).

Inclusion Criteria (asymmetric hearing loss):

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

Exclusion Criteria (Asymmetric hearing loss):

1. Non-English speaker \[Speech perception materials are presented in English\]
2. Medical condition considered a contraindication to undergoing cochlear implantation
3. Conductive hearing loss in either ear
4. Compromised auditory nerve, including those with a history of vestibular schwannoma
5. Ossification
6. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
7. History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia
8. Meniere's disease with intractable vertigo
9. Trauma that precludes inner ear surgery
10. Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
11. Pregnancy \[Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child. Subjects who become pregnant after surgery may continue to participate in study procedures\]
12. Tinnitus as the primary purpose for seeking cochlear implantation
13. Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson \& Spitzer, 1996).

Primary outcomes:
measure: Change in Word Recognition in Quiet Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: 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
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Localization Results (Measured in Variable Error) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Localization Results (Measured in Constant Error) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Localization Results (Measured in Adjusted Constant Error) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: 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)
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: 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
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: 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)
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Secondary outcomes:
measure: Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: 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)
timeFrame: preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)
measure: 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)
timeFrame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
measure: 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)
timeFrame: preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)
timeFrame: preoperative interval and 12 month post-activation interval
measure: Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)
timeFrame: Assessment completed after 12 months of implantable bone-conduction listening experience
measure: Speech Recognition in Noise for a Control Group: BKB-SIN Test
timeFrame: Assessment completed after 12 months of implantable bone-conduction listening experience
measure: Localization for a Control Group
timeFrame: Assessment completed after 12 months of implantable bone-conduction listening experience
measure: Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)
timeFrame: Assessment completed after 12 months of implantable bone-conduction listening experience
measure: Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Assessment completed after 12 months of implantable bone-conduction listening experience
Other outcomes:
measure: Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period
timeFrame: post-activation period (1, 3, 6, and 12 months post-activation)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Margaret Dillon, AuD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.