An interventional study of Hearing and ear health screening in Hearing Loss, Bilateral or Unilateral and Otitis Media With Effusion in Children, sponsored by University of Washington. Recruiting at 1 site in Kenya. Open to participants aged 5 Months to 7 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Washington · Not applicable, Interventional, and Screening
The goal of this observational study is to learn if smartphone hearing screening devices can help to understand the role of ear infections in hearing loss in infants with HIV exposure. The main questions it will answer are 1) What is the screening accuracy of smartphone hearing screening? 2) What is the incidence of ear infections and of abnormal hearing screening findings in infants with and without HIV exposure? Researchers will follow infants with and without HIV exposure for 6 months and will use smartphone and conventional hearing and ear health screening devices at the same time to see if the smartphone devices can help detect ear infections. Parent and infant participants will visit the clinic 3 times over 6 months. At these visits, infants will have hearing and ear health checked using smartphone and conventional devices.
This study will leverage smartphone hearing screening devices to understand the role of otitis media with effusions in hearing loss in infants with HIV exposure. Aim 1 will determine screening accuracy of smartphone-based otoacoustic emissions based hearing screening versus conventional otoacoustic emissions based hearing screening. Hypotheses. Sensitivity and specificity will be high for smartphone otoacoustic emissions testing vs conventional otoacoustic emissions testing. Smartphone otoacoustic emissions testing can detect hearing loss in high-risk infants. Aim 2 will estimate and compare incidence of otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions in infants with and without HIV exposure. Hypothesis. Incidence of otitis media with effusions will be high. Exploratory Hypothesis. HIV exposure will increase the risk of otitis media with effusions.
1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.
This study's planned enrollment of 400 is above the median of 40 across 778 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Infants must meet all of the following criteria:
Exclusion Criteria:
Hearing will be screened using smartphone and conventional devices that detect otoacoustic emissions. Ear health will be screened using a smartphone device that uses acoustic reflectometry to detect middle ear fluid.
Device: Hearing and ear health screening
Hearing will be screened using smartphone and conventional devices that detect otoacoustic emissions. Ear health will be screened using a smartphone device that uses acoustic reflectometry to detect middle ear fluid.
Otitis media with effusions and concurrent abnormal otoacoustic emissions testing with otitis media with effusions.
We will estimate prevalence at each time point and incidence of otitis media with effusions as events per 1000 child weeks.
Time frame: Enrollment, 3 and 6 months follow-up
Screening accuracy of smartphone-based otoacoustic emissions based hearing screening versus conventional otoacoustic emissions based hearing screening.
We will estimate sensitivity and specificity of smartphone OAE, using conventional OAE as a gold standard. We will calculate agreement between smartphone and conventional OAE using Spearman rank correlation coefficients and Kappa test statistics.
Time frame: At enrollment, 3 and 6 months follow-up
Plan to share: Yes — All data other than patient direct or indirect identifiers will be shared.
Access criteria: Other researchers can contact the MPIs and complete an approved Data Sharing Agreement.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 268 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 61. This study's planned 24 months is below that.
Counting every sponsor, half of 444 studies reached it within 17 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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