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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cochlear malformation (except large vestibular aqueduct syndrome)

Retrocochlear lesions

Incomplete implantation of cochlear implant electrodes

Non-Chinese Mandarin communication

Trial design

Design model

Parallel

Treatments tested in this trial

  • cochlear implant

    Device

    Patients enrolled in the study undergo the cochlear implant surgery.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: single-sided deafness group(SSD Group)Experimental treatment 1 intervention
Group B: asymmetric hearing loss group(AHL Group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The tests are conducted before the cochlear implantation.
2

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.

Time frame
The tests are conducted 1 months after CI activation.
3

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.

Time frame
The tests are conducted 3 months after CI activation.
4

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.

Time frame
The tests are conducted 6 months after CI activation.

Secondary outcomes

1

THI (Tinnitus Handicap Inventory)

The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).

Time frame
The test is conducted before the cochlear implantation.
2

THI (Tinnitus Handicap Inventory)

The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).

Time frame
The test is conducted 1 months after CI activation.
3

THI (Tinnitus Handicap Inventory)

The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).

Time frame
The test is conducted 3 months after CI activation.
4

THI (Tinnitus Handicap Inventory)

The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).

Time frame
The test is conducted 6 months after CI activation.

Other outcomes

Sponsors and contacts

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