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Hearing Loss, BilateralHBD-RCTNCT07774728

Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss

A study testing Behind-the-ear (BTE) hearing aids and Hearing-care educational sessions in people with Hearing Loss, Bilateral, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 12 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 4 years
Conditions the study is for
Hearing Loss, Bilateral
What is being tested?
Behind-the-ear (BTE) hearing aids and Hearing-care educational sessions
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
12 sitesChina
Study dates
30 Sep 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

12 sites in 1 country

China12 sites
  • The First People's Hospital of Foshan

    Foshan

    Dr. Yu, 86-757-83833633, wxling86@163.com

    Youjun Yu

  • Guangzhou Women and Children's Medical Center, Guangzhou Medical University

    Guangzhou

    Dr. Wang, 86-20-81886332, wxyaya008@163.co m

    Xiaoya Wang

  • Jiangyin People's Hospital

    Jiangyin

    Dr. Chen, 86-510-86879000, jyrmyyzxl@163.com

    Jinxiang Chen

  • Children's Hospital of Kunming Medical University

    Kunming

    Dr. Ma, 86-871-63169969, 42577491@qq.com

    Jing Ma

  • Liuzhou Maternal and Child Health Hospital

    Liuzhou

    Dr. Tang, 86-772-3312345, 329210776@qq.com

    Xiangrong Tang

  • Children's Hospital of Nanjing Medical University

    Nanjing

  • Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Dr. Ni, 86-21-62474880, 13001710650@163.com

    Kun Ni

  • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Dr. Jiao, 86-21-38626161, ljywzx107@163.com

    Yu Jiao

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011

    Shanghai

    Dr. Wang, +86-21-53314064, zhili_w@163.com

  • West China Hospital, Sichuan University

    Sichuan

    Dr. Meng, 86-28-85422114, xvzhijia@163.com

    Zhaoli Meng

  • Taizhou People's Hospital

    Taizhou

    Dr. Pang, 86-523-962120, pxhzxy@163.com

    Xiuhong Pang

  • Affiliated Hospital of Yan'an University

    Yan’an

    Dr. Song, 86-911-2881002, Jane110005@163.com

    Zhiming Song

Other trials in China

About this study

Official title: 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.

Being tested
Behind-the-ear (BTE) hearing aids, Hearing-care educational sessions
Keywords
Mild hearing loss, Hearing aids, Brain development, Children
Medical subject headings
Hearing Loss, Bilateral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behind-the-ear (BTE) hearing aidsDevice

    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.

  • Hearing-care educational sessionsOther

    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.

Study groups in NCT07774728
Study groupRoleWhat they receive
Hearing-aid interventionExperimentalParticipants 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.
Receives: Device: Behind-the-ear (BTE) hearing aids; Other: Hearing-care educational sessions
Hearing-care educationOtherParticipants 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.
Receives: Other: Hearing-care educational sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Secondary outcomes (10)
  1. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  2. MRI outcomes

    Brain structure and function changes evaluated by MRI

    Measured: Assessed at 0 and 12 months.

  3. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  4. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  5. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  6. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  7. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  8. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  9. 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%).

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

  10. 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.

    Measured: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774728
Sponsor's protocol ID
SH9H-2026-T165
Acronym
HBD-RCT
Status last verified
Sep 2026
First submitted
31 Jul 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Behind-the-ear (BTE) hearing aids and Hearing-care educational sessions in people with Hearing Loss, Bilateral, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhili Wang (+86-21-53314064, zhili_w@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C) (time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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