Clinical trial NCT06689865: Innovations in Hearing Accessibility and Technology (IHAT) Study
Official title: Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Hearing Aids
OTC Hearing Aids
Keywords: hearing loss
hearing aids
OTC hearing aids
service delivery models
effectiveness trial
Over-the-counter hearing aids
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-11-15
Enrollment: 280
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

Detailed description: The aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (OTC) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (HCP) using audiology best practices. OTC service delivery models include OTC HA fit to individual users using best practices with in person HCP support (OTC-HPC), via remote consultation (OTC-R) and self-fit OTC HAs without any clinical support (OTC-SF). The study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.

Eligibility criteria: Inclusion Criteria:

* Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation
* Aged 40 years or older
* No previous HA experience greater than 3 months
* Able to read and understand patient education materials
* Willing to be randomized to one of the four groups, and
* Owns a smartphone

Exclusion Criteria:

* Hearing loss that is too severe for OTC HAs
* Middle ear disorders or conductive pathology present
* Asymmetrical hearing loss
* Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA
* Non-English speaking as it may impact the ability to complete our test battery

Primary outcomes:
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention
Secondary outcomes:
measure: Satisfaction with Amplification in Daily Living (SADL)
timeFrame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
measure: Revised Hearing Handicap Inventory -Screening (RHHI-S)
timeFrame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
measure: Patient Global Impression of Change (PGI-C)
timeFrame: T1= 6 months post intervention, T2= 12 months post intervention
measure: Connected Speech Test (CST)
timeFrame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
measure: Quick Speech in Noise (QuickSIN)
timeFrame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Vinaya Manchaiah, AuD, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: Anu Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376.
citation: De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):765-771. doi: 10.1001/jamaoto.2024.1825.
citation: Knoetze M, Manchaiah V, De Sousa K, Moore DR, Swanepoel W. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):784-791. doi: 10.1001/jamaoto.2024.2007.