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.
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
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.
- Conditions
- Hearing Loss, Bilateral
- 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 group | Role | What they receive |
|---|---|---|
| Hearing-aid intervention | Experimental | 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. Receives: Device: Behind-the-ear (BTE) hearing aids; Other: Hearing-care educational sessions |
| Hearing-care education | Other | 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. Receives: Other: Hearing-care educational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
MRI outcomes
Brain structure and function changes evaluated by MRI
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%).
Measured: 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.
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.
- First posted19 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Wu, Principal investigator, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineHao Wu, Study chair, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hearing Aid Intervention on Brain and Language Development in Children With Bilateral Mild Hearing Loss: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07774728
- Acronym / sponsor ID
- HBD-RCT / SH9H-2026-T165
- Conditions
- Hearing Loss, Bilateral
- Keywords
- Mild hearing loss, Hearing aids, Brain development, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing-aid intervention | Experimental | Device: Behind-the-ear (BTE) hearing aids, Other: Hearing-care educational sessionsParticipants 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. |
| Hearing-care education | Other | Other: Hearing-care educational sessionsParticipants 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. |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behind-the-ear (BTE) hearing aidsBilateral 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. | Device | Hearing-aid intervention |
| Hearing-care educational sessionsStandardized 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-aid intervention, Hearing-care education |
Primary outcome
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.
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.
10 secondary outcomes
Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
MRI outcomes
Time frame: Assessed at 0 and 12 months.
Auditory Brainstem Response (ABR)
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Behavioral audiometry thresholds (Pure-Tone Audiometry)
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Word Recognition Score
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Categories of Auditory Performance (CAP) Score
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Speech Intelligibility Rating (SIR) Score
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Meaningful Auditory Integration Scale (MAIS/IT-MAIS) Score
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Meaningful Use of Speech Scale (MUSS) Score
Time frame: 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)
Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao Wu principal investigator
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Hao Wu study chair
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
12 sites in 1 country: see every site and its status.
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.