Innovations in Hearing Accessibility and Technology (IHAT) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HA-HCP, OTC-HCP, OTC-R, OTC-SF.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Hearing Aids, OTC Hearing Aids. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids
Overview
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.
Interventions
- Device HA-HCP
Prescription hearing aid fit by a hearing healthcare professional using audiology best practices. - Device OTC-HCP
Over-the-counter hearing aids fit by a hearing care professional using audiology best practices. - Device OTC-R
OTC fit to an individual using some best practices via remote consultation. - Device OTC-SF
Self-fit OTC hearing aids without any clinical support from HCPs.
Primary outcome measures
- Abbreviated Profile of Hearing Aid Benefit (APHAB) [Time frame: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention]
Secondary outcome measures (5)
- Satisfaction with Amplification in Daily Living (SADL) [Time frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
- Revised Hearing Handicap Inventory -Screening (RHHI-S) [Time frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
- Patient Global Impression of Change (PGI-C) [Time frame: T1= 6 months post intervention, T2= 12 months post intervention]
- Connected Speech Test (CST) [Time frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
- Quick Speech in Noise (QuickSIN) [Time frame: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Colorado School of Medicine — Aurora
- University of Colorado Boulder — Boulder
Publications
- 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. PMID 37052929
- 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. PMID 38990557
- 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. PMID 39052241
Identifiers
NCT: NCT06689865 · 23-2351 · R01DC021653