Cochlear Implantation in Cases of Single-Sided Deafness

Not Applicable

Completed

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

Interventions: Other: Control Group
Device: Cochlear Implant

Registration Number: NCT02203305

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	A control group without the study intervention (cochlear implantation) will complete the test battery.
Cochlear Implant	Cochlear Implant	Cochlear implantation of the affected ear
Cochlear Implant: Asymmetric hearing loss	Cochlear Implant	Cochlear implantation of the poorer hearing ear

Primary Outcome Measures

Name	Time	Method
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	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Localization Results (Measured in Variable Error) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Localization Results (Measured in Adjusted Constant Error) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Word Recognition in Quiet Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.
Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
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)	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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).
Change in Localization Results (Measured in Constant Error) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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.
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	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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).
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)	Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)	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).

Secondary Outcome Measures

Name	Time	Method
Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)	preoperative interval and 12 month post-activation interval	Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).
Speech Recognition in Noise for a Control Group: BKB-SIN Test	Assessment completed after 12 months of implantable bone-conduction listening experience	The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.
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)	Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. 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.
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)	preoperative interval and 12 month post-activation interval	Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
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)	Subjects completed subjective questionnaires. 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.
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)	preoperative interval and 12 month post-activation interval	Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
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)	preoperative interval and 12 month post-activation interval	Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
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)	preoperative interval and 12 month post-activation interval	Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)	Assessment completed after 12 months of implantable bone-conduction listening experience	Subjects completed subjective questionnaires. 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 average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)	Assessment completed after 12 months of implantable bone-conduction listening experience	Subjects completed subjective questionnaires. 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. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
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)	Subjects completed subjective questionnaires. 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 the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
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)	Subjects completed subjective questionnaires. 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.
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)	preoperative interval and 12 month post-activation interval	Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)	Assessment completed after 12 months of implantable bone-conduction listening experience	The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.
Localization for a Control Group	Assessment completed after 12 months of implantable bone-conduction listening experience	Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device 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. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.
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)	preoperative interval and 12 month post-activation interval	Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).