Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation

Study Overview
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Brief Summary
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Single-sided deafness (SSD) refers to severe to profound sensorineural hearing loss on one side (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) while the opposite side maintains normal hearing or mild hearing loss (30 dB HL). Asymmetrical hearing loss (AHL) refers to severe to profound sensorineural hearing loss in the bad ear (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) and mild to moderate hearing loss in the contralateral ear. Moderate hearing loss (30≤mean pure-tone hearing threshold≤55dBHL). It is generally acknowledged that SSD is a particular clinical manifestation of AHL. The number of people who have hearing loss accounts for 5.3% of the total population, with children for 9%. According to the Second National Sampling Survey on Disabled Persons, China has 27.8 million people with hearing disabilities. The incidence of SSD adults in the United States is 7.2%, with 60,000 new cases per year, compared with 7,500 new patients with SSD annually in the UK. The incidence of SSD in neonates is 0.04%-0.34%, and it ranges from 0.1% to 0.5% in children and adolescents. The etiology of congenital SSD is primarily unknown, which is related to genes. Among the causes of acquired SSD, sudden deafness is the most common. Other causes include head trauma, Meniere's disease, labyrinthitis, unilateral acoustic neuroma, middle ear surgery, ototoxic drug exposure, Virus infection, noise-induced deafness, senile deafness, etc. SSD and AHL impede intellectual development and speech development in children and adolescents, which is associated with the side of hearing loss. For example, children with right-sided hearing loss have relatively poor language learning, logical thinking, and divergent thinking. In contrast, children with left-sided hearing loss have weaker analytical, comprehensive and visual memory abilities and relatively poor spatial imagination and visual-motor coordination. In addition, the lack of long-term monaural listening and sound source localization makes SSD children require excessive concentration, which is prone to fatigue and behavioral problems, and their academic performance is lower than that of normal children.

Detailed Description
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Current options for hearing interventions for patients with SSD are air conduction hearing aids, bone conduction hearing aids and cochlear implants. Attributed to the United States Food and Drug Administration (FDA) approval of one manufacturer's CI for patients aged five years and older with SSD in 2019, CI has been considered by the growing population. However, few studies on CI in patients with SSD, especially in China. Therefore, the study aims to evaluate the efficacy of CI in SSD patients.

Official Title
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Evaluation of Rehabilitation Results in the Single-sided Deafness/Asymmetrical Hearing Loss With Cochlear Implantation

Conditions
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Unilateral Deafness

Intervention / Treatment
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* Device: cochlear implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 12 years old and above Language ability: postlingual deafness, able to cooperate with sentence test in noise Normal mental, intelligence and motor development Patients who meet the diagnosis of single-sided deafness and asymmetric hearing loss Exclusion Criteria: Cochlear malformation (except large vestibular aqueduct syndrome) Retrocochlear lesions Incomplete implantation of cochlear implant electrodes Non-Chinese Mandarin communication

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-sided deafness group（SSD Group）<br>The single-sided group（SSD group）consists of 20 SSD patients voluntarily enrolled in the study and plan to undergo cochlear implantation. | Device: cochlear implant<br>* Patients enrolled in the study undergo the cochlear implant surgery.<br>|
| Experimental: asymmetric hearing loss group（AHL Group）<br>The asymmetric hearing loss group（AHL group）consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation. | Device: cochlear implant<br>* Patients enrolled in the study undergo the cochlear implant surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech recognition | Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication. | The tests are conducted before the cochlear implantation. | 
| speech recognition | Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication. | The tests are conducted 1 months after CI activation. | 
| speech recognition | Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication. | The tests are conducted 3 months after CI activation. | 
| speech recognition | Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication. | The tests are conducted 6 months after CI activation. | 
| speech recognition | Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication. | The tests are conducted 12 months after CI activation. | 
| sound localization | 180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation). | The test is conducted before the cochlear implantation. | 
| sound localization | 180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation). | The test is conducted 1 months after CI activation. | 
| sound localization | 180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation). | The test is conducted 3 months after CI activation. | 
| sound localization | 180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation). | The test is conducted 6 months after CI activation. | 
| sound localization | 180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation). | The test is conducted 12 months after CI activation. | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | The test is conducted before the cochlear implantation. | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | The test is conducted 1 months after CI activation. | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | The test is conducted 3 months after CI activation. | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | The test is conducted 6 months after CI activation. | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | The test is conducted 12 months after CI activation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THI (Tinnitus Handicap Inventory) | The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale). | The test is conducted before the cochlear implantation. | 
| THI (Tinnitus Handicap Inventory) | The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale). | The test is conducted 1 months after CI activation. | 
| THI (Tinnitus Handicap Inventory) | The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale). | The test is conducted 3 months after CI activation. | 
| THI (Tinnitus Handicap Inventory) | The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale). | The test is conducted 6 months after CI activation. | 
| THI (Tinnitus Handicap Inventory) | The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale). | The test is conducted 12 months after CI activation. | 
| SSQ12 (Speech, Spatial and Qualities of Hearing Scale) | SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality. | The test is conducted before the cochlear implantation. | 
| SSQ12 (Speech, Spatial and Qualities of Hearing Scale) | SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality. | The test is conducted 1 months after CI activation. | 
| SSQ12 (Speech, Spatial and Qualities of Hearing Scale) | SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality. | The test is conducted 3 months after CI activation. | 
| SSQ12 (Speech, Spatial and Qualities of Hearing Scale) | SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality. | The test is conducted 6 months after CI activation. | 
| SSQ12 (Speech, Spatial and Qualities of Hearing Scale) | SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality. | The test is conducted 12 months after CI activation. | 
| QLBHE (Quality of Life for Bilateral Hearing Effect) | QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices. | The test is conducted before the cochlear implantation. | 
| QLBHE (Quality of Life for Bilateral Hearing Effect) | QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices. | The test is conducted 1 months after CI activation. | 
| QLBHE (Quality of Life for Bilateral Hearing Effect) | QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices. | The test is conducted 3 months after CI activation. | 
| QLBHE (Quality of Life for Bilateral Hearing Effect) | QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices. | The test is conducted 6 months after CI activation. | 
| QLBHE (Quality of Life for Bilateral Hearing Effect) | QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices. | The test is conducted 12 months after CI activation. | 
| NCIQ (Nijmegen Cochlear Implant Questionnaire) | The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function. | The test is conducted before the cochlear implantation. | 
| NCIQ (Nijmegen Cochlear Implant Questionnaire) | The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function. | The test is conducted 1 months after CI activation. | 
| NCIQ (Nijmegen Cochlear Implant Questionnaire) | The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function. | The test is conducted 3 months after CI activation. | 
| NCIQ (Nijmegen Cochlear Implant Questionnaire) | The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function. | The test is conducted 6 months after CI activation. | 
| NCIQ (Nijmegen Cochlear Implant Questionnaire) | The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function. | The test is conducted 12 months after CI activation. |