Health TrialsbyHealthPanel

Improving Access and Affordability of Adult Hearing Healthcare

ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Alabama, Tuscaloosa

About this trial

This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Mild-to-moderate hearing loss

Live in West Central or South Alabama

40 years of age or older

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Hearing Evaluation

    Behavioral

    Behavioral thresholds for pure tones will be conducted along with speech perception measures.

  • Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation

    Device

    Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.

  • Four Weeks of Aural Rehabilitation

    Behavioral

    Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.

  • Provision of Over-the-Counter Hearing Aids

    Device

    Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)Experimental treatment 3 interventions
Group B: Audiology Best Practices (ABP)Active comparator 2 interventions
Group C: Over-the-Counter Only (OTC-Only)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Measuring Change in the Hearing Handicap Inventory for Elderly (HHIE) Outcomes

Twenty-five questions of the Hearing Handicap Inventory for Elderly (HHIE) measure emotional and social/situational consequences of hearing loss, including feelings of embarrassment, social isolation, and frustration. Scores range from 0 to 100 with higher scores indicative of poorer performance.

Time frame
A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
2

Measuring Change in International Outcome Inventory for Hearing Aids (IOI-HA) Outcomes

The International Outcome Inventory for Hearing Aids (IOI-HA) is an eight-item inventory that assesses daily use of over-the-counter hearing aid use, over-the-counter hearing aid benefit, and activity limitations to name a few. This is a scaled qualitative measure that assesses outcomes over time.

Time frame
A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.

Secondary outcomes

1

Measuring Change in Northwestern University-6 (NU-6) Word Recognition Outcomes

This test will assess word recognition in quiet. Binaural testing will be performed at 65 dBA in the sound field. A percentage correct word understanding will be obtained. A higher scores is indicative of better performance.

Time frame
A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 8 to 9 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
2

Measuring Change in Quick Speech In Noise (SIN) Word Recognition Outcomes

The participant will be instructed to repeat the presented sentences in noise via a speaker presented at 0˚ azimuth. The correctly identified target words will be totaled and then subtracted from 25.5 to obtain the Signal-to-Noise Ratio (SNR) loss. A higher score is indicative of poorer performance.

Time frame
A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 8 to 9 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
3

Measuring Change in the Client Oriented Scale of Improvement (COSI)

The Client Oriented Scale of Improvement (COSI) is a 16-item clinician-administered survey that addresses how the participants' five most important listening difficulties have been alleviated with over-the-counter hearing aid use. This is a qualitative scale that measures improvement over time.

Time frame
A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.
4

Measuring Change in the Abbreviated Profile of Hearing Aid Benefit (APHAB)

The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item survey that computes OTC HA-benefit by calculating the difference between aided and unaided conditions. It is a qualitative scale that measures the extent of change over time.

Time frame
A baseline outcome will be obtained prior to over-the-counter hearing aid fitting. Outcomes will be measured at weeks 4 to 7 of intervention, during week 14 of the intervention, and through study completion, or 1 assessment each year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama, Tuscaloosa

Lead sponsor

University of Alabama at Birmingham

Collaborator

Source ClinicalTrials.gov
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