Hearing Loss, Bilateral
Conditions
Keywords
Mild hearing loss, Hearing aids, Brain development, Children
Brief summary
This is a multicenter, prospective, randomized controlled clinical trial to evaluate the effects of hearing aid intervention on brain and language development in children with bilateral mild sensorineural hearing loss. Eligible participants will be randomly assigned (1:1) to either the hearing aid intervention group or the control group. The primary outcome is the general developmental quotient of the Griffiths Development Scales-Chinese Edition (GDS-C) at 12 months. Secondary outcomes include auditory and speech development, language development, adaptive behavior, and brain structure and function assessed by MRI. Follow-up assessments will be conducted at baseline, 6 months, and 12 months.
Interventions
DEVICEBehind-the-ear (BTE) hearing aids
Bilateral BTE hearing aids will be uniformly provided by the project team and fitted and verified by experienced audiologists at participating sites, with settings adjusted to achieve optimal hearing status according to individual needs. The devices will be selected from mainstream BTE hearing aid brands and models that are already commercially available in China and widely used in pediatric populations.
OTHERHearing-care educational sessions
Standardized educational sessions covering children hearing and speech development, pediatric hearing care, routine monitoring and detection, and appropriate family support and parent-child interaction delivered by trained researchers during each follow-up visit.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No
Inclusion criteria
* Age: ≥0.5 years and \<4 years * Diagnosed with bilateral mild sensorineural hearing loss by objective hearing tests: bilateral click-ABR ≥35 dB nHL and ≤50 dB nHL, with bilateral type A tympanogram (including As/Ad type) on acoustic immittance testing * Without previous hearing aid intervention
Exclusion criteria
* Premature and low birth weight infants: gestational age less than 37 weeks, or birth weight below 2500 grams * Participants diagnosed with enlarged vestibular aqueduct (EVA) by imaging (CT, MRI) or genetic testing * Participants with complicated medical problems or significant disabilities affecting growth and development (such as autism, recurrent epilepsy, severe heart disease requiring multiple surgeries, etc.) and considered unsuitable for this study by the investigators * Families who refused to participate in this study, or have already decided whether the participant will wear hearing aids or not (refused to randomization). * Participants who refused/was unable to undergo study assessments as scheduled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C) | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | The GDS-C was adapted from the 2006 Griffiths Mental Development Scales - Extended Revised (GMDS-ER) and standardized with Chinese norms for children aged 0-8 years. It evaluates six subdomains: (A) Locomotor, (B) Personal-Social, (C) Language, (D) Eye \& Hand Coordination, (E) Performance, and (F) Practical Reasoning. The General Developmental Quotient (GDQ) is derived as:(developmental age ÷ chronological age) × 100. Higher scores indicate better overall developmental status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | Including six subscales: Locomotor (A), Personal-Social (B), Language (C), Eye-hand Co-ordination (D), Performance (E), and Practical Reasoning (F). Each subscale quotient is calculated as (subscale developmental age ÷ chronological age) × 100. Higher subscale quotients indicate better performance in the specific domain. |
| MRI outcomes | Assessed at 0 and 12 months. | Brain structure and function changes evaluated by MRI |
| Auditory Brainstem Response (ABR) | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve. The ABR threshold will be measured in decibels normal hearing level (dB nHL) for each ear. Lower thresholds indicate better auditory function. |
| Behavioral audiometry thresholds (Pure-Tone Audiometry) | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | Behavioral audiometry measures the lowest pure tone level children can respond. Its thresholds will be measured in decibels hearing level (dB HL) for each ear at standard frequencies. The Pure Tone Average (PTA) will be calculated by the average of four frequencies (0.5, 1, 2, 4 kHz). Lower thresholds indicate better hearing. |
| Word Recognition Score | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | Measured by percentage of correctly identified words (ranging from 0% to 100%) from standardized Mandarin Chinese word lists, presented in a quiet sound booth. Higher percentages indicate better speech perception ability. |
| Categories of Auditory Performance (CAP) Score | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | The Categories of Auditory Performance (CAP) is a hierarchical rating scale assessing real-life auditory functioning. It comprises 10 categories graded from 0 to 9, where 0 = "cannot detect environmental or speech sounds" and 9 = "able to use the telephone with an unfamiliar speaker in unpredictable situations". Higher scores indicating better auditory performance. |
| Speech Intelligibility Rating (SIR) Score | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | The Speech Intelligibility Rating (SIR) is a hierarchical rating scale assessing the intelligibility of a child's speech in everyday communication. It comprises 5 categories graded from 1 to 5, with higher scores indicating greater speech intelligibility. |
| Meaningful Auditory Integration Scale (MAIS/IT-MAIS) Score | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | This scale includes the original MAIS version for children aged ≥3 years and the IT-MAIS (Infant-Toddler version) for children \<3 years. It is a parent-report structured interview designed to assess the child's spontaneous auditory responses in everyday environments, consisting of 10 items evaluating three domains: vocalization behavior, alerting to sounds, and deriving meaning from sound. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40. Higher scores indicate better auditory integration ability. |
| Meaningful Use of Speech Scale (MUSS) Score | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | The Meaningful Use of Speech Scale (MUSS) assesses speech production and communication ability. It comprises 10 open-ended questions answered by parents/guardians, each scored 0-4). The total score ranges from 0 to 40, with higher scores indicating better speech use. Scores are often reported as percentages (score ÷ 40 × 100%). |
| Adaptive behavior measured by Adaptive Behavior Assessment System, Second Edition (ABAS-II) | From enrollment to 12 months, with assessments at 0, 6, and 12 months. | The ABAS-II is a comprehensive, norm-referenced assessment of adaptive functioning across multiple skill areas relevant to daily living. Depending on the respondent form used, it yields a General Adaptive Composite (GAC) as an overall standard score (mean = 100, SD = 15), three domain composite scores (Conceptual, Social, and Practical), and individual skill area scaled scores covering domains such as Communication, Community Use, Functional Academics, Home Living, Health and Safety, Leisure, Self-Care, Self-Direction, Social, Work (where applicable), and Motor. Higher scores consistently indicating more advanced adaptive functioning. |
Countries
China
Contacts
CONTACTZhili Wang
PRINCIPAL_INVESTIGATORHao Wu
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
STUDY_CHAIRHao Wu
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed