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Children with Unilateral Hearing Loss (CUHL) study: Does early hearing device fitting improve language and psychosocial outcomes?

Does early hearing device fitting improve language and psychosocial outcomes of children with congenital hearing loss in one ear?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000651583
Acronym
CUHL
Enrollment
179
Registered
2015-06-24
Start date
2014-12-15
Completion date
2018-09-18
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite early detection of congenital unilateral hearing loss (UHL) via universal newborn hearing screening (UNHS), there is a lack of evidence on the efficacy of early intervention (in the form of device fitting) for improving outcomes, and the benefit vs harms of early detection and treatment is uncertain. Consequently, there is clinical equipoise concerning whether children should receive amplification (as well as surveillance). The overall goal of this project is to determine the efficacy of device intervention for improving outcomes of children diagnosed with permanent unilateral hearing loss at or shortly after birth. The aims are to: 1) investigate the impact of early detection and treatment of UHL on the child and family; 2) determine factors affecting outcomes at 3 years of age for children with congenital UHL; and 3) assess the efficacy of device fitting on improving outcomes. The results of this research will provide the much-needed evidence-based guidance for clinical practice.

Interventions

Despite early detection of congenital Unilateral Hearing Loss (UHL) via universal newborn hearing screening (UNHS), there is a lack of evidence on the efficacy of early intervention (in the form of device fitting) for improving outcomes, and the benefit vs harms of early detection and treatment is uncertain. This study will follow children from diagnosis to 3 years of age to investigate the impact of UHL, and examine the benefit (if any) of device fitting. By agreeing to participate, a child wi

Despite early detection of congenital Unilateral Hearing Loss (UHL) via universal newborn hearing screening (UNHS), there is a lack of evidence on the efficacy of early intervention (in the form of device fitting) for improving outcomes, and the benefit vs harms of early detection and treatment is uncertain. This study will follow children from diagnosis to 3 years of age to investigate the impact of UHL, and examine the benefit (if any) of device fitting. By agreeing to participate, a child with a unilateral hearing impairment would be allocated to one of two groups, 1) a device ‘fitting’ group , or 2) a ‘no fitting’ group. By participating in the study, all families and their children will be offered a study-specific program of support commensurate with best practice. Parents will be asked to complete a consent form before being informed as to which group their child has been allocated. For children assigned to the ‘fitting’ group, each child’s Australian Hearing (AH) clinician will choose a device in consultation with the child’s parents, and fit the device in accordance with standard procedures. All families in both groups will be offered a support program that involves intensive monitoring through tympanometry every 3 months. If a child consistently exhibits middle ear disorders in the good ear for longer than 6 months, the child will be referred to AH for review (and potential fitting), irrespective of experimental assignment. Standard audiometry will be offered annually, around the time of outcomes assessments. Significant changes in hearing thresholds will be referred to AH audiologists. In addition, all parents will be provided with a starter kit that contains information on childhood unilateral hearing loss, child development, communication strategies and activities on how to help the child, and where to get further support if needed. All families will also be offered access to information sessions to be organised by parent-support groups throughout the duration of the study.

Sponsors

National Acoustic Laboratories, Australian Hearing
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 12 Months
Healthy volunteers
No

Inclusion criteria

Children born between May 2014 and June 2017 in NSW, VIC and QLD who were diagnosed as having a permanent unilateral hearing loss via UNHS.

Exclusion criteria

Diagnosis of bilateral hearing loss

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026