Longitudinal Outcomes of Hearing Aids

Study Overview
=================
Brief Summary
-----------------
Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery models to compensate for their impaired hearing. Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.

Detailed Description
-----------------
Although hearing aids (HAs) are the first treatment of choice for age-related hearing loss, only 15-30% of those older Americans who could benefit, actually seek HAs out and use them. HA adoption rates are even lower for people with lower income and for racial and ethnic minorities. Although the answer to why so few older adults seek or use amplification is multidimensional, one common thread is that many people believe that HAs fitted using the audiologist-based model cost too much. Therefore, it is not surprising that there has been increased advocacy for a variety of over-the-counter (OTC) service-delivery models, which have increasingly been identified as important options for managing mild-to-moderate age-related hearing loss. Is the amplification intervention delivered using the OTC model an appropriate solution for age-related hearing loss? Although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The purpose of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months. Older adults with age-related hearing loss will be recruited. Pre-configured hearing aids (that simulate OTC hearing aids) will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. HA outcomes will be measured at 6-week and 12-week post intervention.

Official Title
-----------------
Longitudinal Outcomes of Over-the-Counter Hearing Aids

Conditions
-----------------
Presbycusis

Intervention / Treatment
-----------------
* Device: Over-the-counter fitting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss Exclusion Criteria: Non-native speaker of English

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTC Group<br>In this group, the over-the-counter fitting will be used to provide hearing aids. | Device: Over-the-counter fitting<br>* In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) | The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using an ecological momentary assessment methodology. The name of the mobile device app is AudioSense2. The score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome. | Change between 6-week post intervention and 12-week post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance / Profile of Hearing Aid Benefit (PHAP / PHAB) | The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance). The score difference between two PHAP (i.e., 6-week post intervention and 12-week post-intervention) is PHAB. | Change between 6-week post intervention and 12-week post-intervention | 
| Change of Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) | The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 24 (more handicap). | Change between 6-week post intervention and 12-week post-intervention | 
| Change of Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS) | The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction). | Change between 6-week post intervention and 12-week post-intervention | 
| Willingness-to-pay | Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study. | 12-week post intervention | 
| Change of Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) | The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability). | Change between 6-week post intervention and 12-week post-intervention | 
| Change of Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) | The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction). | Change between 6-week post intervention and 12-week post-intervention | 
| Change of Speech recognition performance as measured by the Connected Speech Test (CST) | The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech). | Change between 6-week post intervention and 12-week post-intervention | 
| Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (paper-and-pencil administration) | The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using a paper-and-pencil format. he score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome. | Change between 6-week post intervention and 12-week post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Presbycusis, Hearing aid