Evaluating long-term effects of osseointegrated devices on hearing and cognition
Official title: Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Run by University of South Florida · NCT04899037 · Data updated 2026-11-12
This study is trying to see how using special hearing devices affects the thinking and daily life of people with hearing loss over three years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | January 29, 2021 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT04899037 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are community-dwelling adults aged 18-85 with specific types of hearing impairment who are fluent in English and at risk for cognitive decline.
✕Probably not a fit
Patients with significant disabilities in daily living activities or those with substantial cognitive impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the long-term cognitive and functional outcomes of patients with hearing loss who utilize osseointegrated devices (OID) compared to those who do not. Participants aged 18-85 will be followed for three years to evaluate changes in global cognitive function, hearing performance, quality of life, and social interactions. The study will focus on individuals with conductive, mixed, or unilateral hearing loss and will analyze the impact of OID intervention on various secondary outcomes. The research seeks to fill gaps in understanding the relationship between hearing interventions and cognitive decline.
Why it matters
Potential benefit: If successful, this study could provide insights into how osseointegrated devices may improve cognitive function and quality of life for patients with hearing loss.
How similar studies have gone: While there is limited research specifically on osseointegrated devices and cognitive outcomes, similar studies have shown promising results in the relationship between hearing interventions and cognitive health.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-85 years * community dwelling * residency: participants must plan to reside in the local area for the study duration. * fluent English-speaker * Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention. * Mini-Mental State Exam (MMSE) score \> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline. * willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years) Exclusion Criteria: * self-reported disability in \>2 or more Activities of Daily Living (ADL) * medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded
Where it's running
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Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab
Tampa, Florida, United States Recruiting
Study contacts
- Principal investigator: Victoria Sanchez, Au.D, Ph.D — University of South Florida
- Study coordinator: Marsadi L. Parliament, Audiologist, Co-Investigator, Au.D.
- Email: marsadi@usf.edu
- Phone: 813-974-1262
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transitioning from Baha Connect to Osia System in adults with mixed or conductive hearing loss
This study tests whether the Osia System is safe and performs well in adults who already use a Baha Connect system and want to switch.
-
Hearing screening for preschool children
This study is testing two different ways to check hearing in preschool children to see which method works better for finding hearing loss early and helping kids who might struggle with speech and language.
-
Open-label test of a spectacle hearing aid to check safety and effectiveness
This will test whether a hearing aid built into eyeglasses helps adults with mild to moderate hearing loss who wear corrective glasses.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.