Innovations in Hearing Accessibility and Technology (IHAT) Study

NCT06689865 | Recruiting DMC FDA Device

• 2 other identifiers: 23-2351R01DC021653
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Abbreviated Profile of Hearing Aid Benefit (APHAB)

  It is a 24-item self-reported measure of hearing disability and hearing aid benefit. It includes four subscales that address different listening challenges: ease of communication, reverberation, background noise, and aversiveness of sounds, with each subscales comprising six items. The ease of communication, reverberation, and background noise primarily measure challenges related to speech communication. The global score on the APHAB is the average of these three subscale scores. The hearing aid benefit is calculated by comparing the difficulty level reported without amplification (unaided) to the difficulty level with amplification (aided). Scores range from 1% to 99%, with higher scores indicating greater perceived hearing difficulty.

  T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention

Secondary Outcomes (5)

• Satisfaction with Amplification in Daily Living (SADL)

  T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention

• Revised Hearing Handicap Inventory -Screening (RHHI-S)

  T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention

• Patient Global Impression of Change (PGI-C)

  T1= 6 months post intervention, T2= 12 months post intervention

• Connected Speech Test (CST)

  T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention

• Quick Speech in Noise (QuickSIN)

  T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention

Study Arms (4)

HA-HCP

ACTIVE COMPARATOR

Device: HA-HCP

OTC-HCP

EXPERIMENTAL

Device: OTC-HCP

OTC-R

EXPERIMENTAL

Device: OTC-R

OTC-SF

ACTIVE COMPARATOR

Device: OTC-SF

Interventions

HA-HCP DEVICE

Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.

HA-HCP

OTC-HCP DEVICE

Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.

OTC-HCP

OTC-R DEVICE

OTC fit to an individual using some best practices via remote consultation.

OTC-R

OTC-SF DEVICE

Self-fit OTC hearing aids without any clinical support from HCPs.

OTC-SF

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Boulder

Boulder, Colorado, 80305, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vinaya Manchaiah, AuD, MBA, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Anu Sharma, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Service Professional

CONTACT

303-724-8465; ihat@cuanschutz.edu

Preeti Pandey, PhD

CONTACT

preeti.pandey@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (2)