Recruiting

Osseointegrated Device

Sponsor:

University of South Florida

Code:

NCT04899037

Conditions

Hearing Loss, Conductive

Hearing Loss, Mixed

Deafness, Unilateral

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)

Conditions

Hearing Loss, Conductive

Hearing Loss, Mixed

Deafness, Unilateral

Study ID

NCT04899037

Start date

Jan 29, 2021

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Osseointegrated Device Uptake

The participants in this group will be in the 18-85 year age range who have a hearing loss configuration that would benefit from an OID and choose to uptake an OID.

Osseointegrated Device Non Uptake

The participants in this group will be in the 18-85 year age range and who a hearing loss configuration that would benefit from an OID but choose to not uptake an OID.

Interventions

No intervention

This is an observational study of participants that either choose or not choose to utilize an OID. This is not an intervention prescribed study, however, participants may choose uptake of standard of care intervention and obtain and utilize an OID. An OID is an FDA-approved device commonly recommended to patients with conductive, mixed, or singled-sided hearing loss. There is no experimental intervention evaluated in this study.

Primary outcome measure

  • Change from baseline to month 36 on Ensuring Speech Understanding Test scores, evaluating a participants ability to hear the examiner during the Neurocognitive Test Battery [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Mini Mental State Exam scores, evaluating cognitive function ability [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Delayed Word Recall Test scores, evaluating verbal memory [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Digit Symbol Substitution Test scores, evaluating psychomotor speed and sustained attention [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Incidental Learning Test scores, evaluating non-verbal recent memory [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Trail Making Test Part A (TMT A) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Trail Making Test Part B (TMT B) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function [ Time Frame: Baseline and Month 36 ]
  • Change from baseline to month 36 on Logical Memory I and II scores, evaluating immediate and delayed verbal recall [ Time Frame: Baseline to Month 36 ]
  • Change from baseline to month 36 on Digit Span Backwards scores, evaluating attention and working memory [ Time Frame: Baseline to Month 36 ]
  • Change from baseline to month 36 on Boston Naming Test scores, evaluating visual naming ability [ Time Frame: Baseline to Month 36 ]
  • Change from baseline to month 36 on Word Fluency Test scores, evaluating verbal functioning [ Time Frame: Baseline to Month 36 ]
  • Change from baseline to month 36 on Animal Naming Test scores, evaluating category fluency [ Time Frame: Baseline to Month 36 ]

Central Contacts and Locations

Central contacts

Marsadi L. Parliament, Audiologist, Co-Investigator, Au.D.

813-974-1262marsadi@usf.edu

Morgan Oktela, Audiologist, Au.D.

813-974-1262moktela@usf.edu

Locations

Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab

Recruiting

Tampa, Florida, United States, 33613

Contacts

Marsadi L Parliament, AuD Co-Investigator, Au.D

813-974-1262marsadi@usf.edu

Morgan Oktela, Au.D.

813-974-1262moktela@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • osseointegrated device
  • cognition
  • hearing loss
  • neurocognitive
  • BAHA
  • Ponto
  • Osseointegrated Bone-Conducting Hearing Protheses
  • Osia
  • Osseointegrated Auditory Device
  • Auditory Wellness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-09-09.