Cochlear Implant, Hearing Loss
Conditions
Keywords
Multimodal Acoustic Therapy, Cochlear Implant, Pediatric Cochlear Implant Users, Adolescent Cochlear Implant Users, Auditory Rehabilitation, Mobile Application, Digital Health Intervention
Brief summary
This exploratory, single-center, single-arm study investigates the impact of a 12-week Multimodal Acoustic Therapy (MAT) intervention followed by a 12-week follow-up period on both objective and subjective auditory perception in pediatric cochlear implant users.
Detailed description
Duration of study period (per participant): 24 weeks, including a 12-week intervention and a 12-week online follow-up. Participants will use the Multimodal Acoustic Therapy (MAT) mobile application at home for 12 weeks to improve music and speech perception. Participants will visit the site twice (baseline and post-intervention), while all other evaluations, including follow-up, will be conducted online. The first on-site visit is mainly to on-board participants and to train them for accurate use of the intervention.
Interventions
DEVICEMobile Auditory Rehabilitation
Mobile Application for Auditory Rehabilitation
Sponsors
BELL Therapeutics Inc.
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with cochlear implants * Korean patients aged 10 to 19 years * Capable of using a smartphone * Scored ≤80% on MCI pre-assessment * Voluntarily agreed to participate in this study
Exclusion criteria
* Has systemic medical conditions (e.g., cancer, stroke) that limit daily functioning * Has intellectual disability, congenital malformation, or other neurological disorders affecting language or cognitive abilities * Has diagnosed emotional disorders such as depression or anxiety * Primarily uses sign language for daily communication * Has undergone cochlear implant revision surgery * Has prior experience with the investigational auditory rehabilitation application used in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melody Contour Identification (MCI) | 12 weeks | Participants complete a melody contour identification task in which they listen to brief melodic sequences and select the contour pattern (e.g., rising, falling, flat). Performance is quantified as the percentage of correctly identified contours (% correct). Higher scores indicate better melody contour perception. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parents' Evaluation of Aural/Oral Performance of Children (PEACH) | 12 weeks | Auditory performance in everyday listening situations will be evaluated using the Parents' Evaluation of Aural/Oral Performance of Children (PEACH) questionnaire. Parents rate their child's functional auditory behaviors across quiet and noisy environments. Scores are converted to a percentage (0-100%), with higher scores indicating better auditory performance. The PEACH is a parent-proxy assessment tool, consistent with its standard scoring procedure. |
| Quality of Life - Cochlear Implants (Parent-Proxy Report) | 12 weeks | Quality of life specific to pediatric cochlear implant users will be assessed using the Quality of Life - Cochlear Implants (CI-QOL) questionnaire. This is a parent-proxy reported measure, in which parents rate their child's auditory-related daily functioning, communication abilities, social participation, and emotional well-being. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| Emotional Prosody Perception Test (EPP) | 12 weeks | Performance will be reported as the percentage. Higher percentages indicate better emotional prosody perception. |
| Music-Related Quality of Life (MuRQoL) | 12 weeks | Each item is rated on a 1-5 Likert scale, and domain scores may be converted to a normalized 0-100 scale. Higher scores indicate better music-related quality of life. |
| Sentence Test in Quiet | 4 weeks | Performance will be reported as the percentage of correctly repeated sentences (% correct). Higher percentages indicate better speech recognition ability. |
| Speech test in Noise | 4 weeks | Sentence recognition will be assessed using standardized sentence materials presented in background noise at a +5 dB signal-to-noise ratio (SNR), where the noise level is higher relative to the speech signal. Performance will be reported as the percentage of correctly repeated sentences (% correct). Lower percentages are expected compared to quiet due to increased listening difficulty; higher percentages indicate better speech-in-noise perception ability. |
| Monosyllabic Word Test | 4 weeks | Performance will be reported as the percentage of correctly identified words (% correct). Higher percentages indicate better auditory word recognition ability. |
Countries
South Korea
Outcome results
None listed