Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss (HBD-RCT)

Effects of Hearing Aid Intervention on Brain and Language Development in Children With Bilateral Mild Hearing Loss: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Bilateral
• Intervention / Treatment: Device: Behind-the-ear (BTE) hearing aids; Other: Hearing-care educational sessions

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhili Wang; Phone Number: +86-21-53314064; Email: zhili_w@163.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
    • Contact: Zhili Wang Zhili Wang Zhili Wang; Phone Number: +86-21-53314064; Email: zhili_w@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hearing-aid intervention; Participants in the hearing-aid intervention group will receive standardized bilateral fitting of behind-the-ear (BTE) hearing aids, and their parents will be instructed to ensure consistent daily use for 12 months and be provided with essential knowledge regarding hearing aid maintenance and proper usage. In addition, the same hearing-care education sessions will also be delivered to this group.	Device: Behind-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.; Other: Hearing-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.
Other: Hearing-care education; Participants in the hearing-care education control group will not receive hearing aids, but will receive standardized hearing-care educational sessions at each follow-up visit.	Other: Hearing-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
MRI outcomes	Brain structure and function changes evaluated by MRI	Assessed at 0 and 12 months.
Auditory Brainstem Response (ABR)	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Behavioral audiometry thresholds (Pure-Tone Audiometry)	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Word Recognition Score	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Categories of Auditory Performance (CAP) Score	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Speech Intelligibility Rating (SIR) Score	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Meaningful Auditory Integration Scale (MAIS/IT-MAIS) Score	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Meaningful Use of Speech Scale (MUSS) Score	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%).	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Adaptive behavior measured by Adaptive Behavior Assessment System, Second Edition (ABAS-II)	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.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio	DPOAEs were recorded bilaterally at standard frequencies. For each frequency, the DPOAE amplitude (in dB SPL) and signal-to-noise ratio (SNR, in dB) were obtained. The amplitude represents the absolute sound pressure level of the distortion product response, while the SNR is the difference between the amplitude and the background noise floor at the same frequency. Higher amplitude and SNR indicate stronger outer hair cell (OHC)-mediated cochlear amplification and better cochlear function. A DPOAE response is conventionally considered present (PASS) when the SNR exceeds 6 dB.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Acoustic Immittance	Acoustic immittance is measured via tympanometry using a 226-Hz probe tone. Three quantitative parameters are reported: tympanometric peak pressure (measured in daPa), peak compensated static admittance (measured in mmho), and equivalent ear canal volume (measured in mL). Results are classified as pass or fail based on standardized criteria.	From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Family Environment Survey	Including basic family environment survey, and Index of Child Care Environment (ICCE)	From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Study Chair: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: August 17, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Children; Hearing aids; Brain development; Mild hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Bilateral; Equipment and Supplies; Electrical Equipment and Supplies; Wearable Electronic Devices; Sensory Aids; Hearing Aids
• Other Study ID Numbers: SH9H-2026-T165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The protocol will be available from study initiation, before the first participant is enrolled. The final version of SAP will be approved before database lock and will be shared 6 months after the primary results are published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No