Longitudinal Outcomes of Over-the-Counter Hearing Aids
Phase: NA
Conditions: Presbycusis
Sponsor: Yu-Hsiang Wu

 
 
Official Title of the study: Longitudinal Outcomes of Hearing Aids  
 
NCT number: NCT04030299  
 
Date of the document: 3/9/2022 
 
 

 
2 
Study Protocol 
Longitudinal Outcomes of Hearing Aids 
 
1 
Background 
Hearing aids (HAs) have been shown to improve communication ability, hearing-specific quality of 
life, and social and emotional function. Additionally, HAs have the potential to reduce cognitive 
decline in older adults at increased risk. Despite these benefits, HA adoption rates remain quite low. 
The reasons for this low HA adoption rate are multidimensional, with one widely cited reason being 
the financial and physical barriers to accessing traditional HA fitting services and amplification 
devices. 
In recent years, the over-the-counter (OTC) service-delivery model has emerged as an alternative to 
traditional HAs. OTC HAs enable users to self-determine hearing loss and self-fit the device without 
professional support. While previous research exists on the short-term outcomes of OTC HAs, there 
is no evidence on the long-term outcomes of OTC HAs and whether these outcomes worsen, 
improve, or remain stable over time. 
 
2 
Purpose 
To explore the trajectory of long-term outcomes of OTC HAs over a period of twelve weeks. 
 
3 
Research Design 
3.1 
Overview 
This study is an observational study. Participants will use OTC HAs for twelve weeks. Outcomes 
will be measured at the first week, sixth week, and twelfth week post-HA use. 
 
3.2 
Intervention 
OTC Group: In this group, preset-based OTC HAs, simulated using commercially available HAs, 
will be provided to subjects. Subjects will take the full initiative and responsibility for learning and 
using the HAs without assistance from audiologists. 
 
3.3 
Sample size 
Because this is an exploratory study, no power analysis is conducted to determine the sample size. 
Based on prior research experience, it is estimated that approximately 34 participants are needed to 
see the trend of long-term HA outcomes. 
 
3.4 
Randomization and blinding 

 
3 
All participants will be assigned to the OTC group. Therefore, blinding will not be necessary. 
 
3.5 
Participant eligibility criteria 
3.5.1 Inclusion: Inclusion Criteria: 
• 
Adults between 55 and 85 years old 
• 
Adult-onset, bilateral, mild-to-moderate sensorineural hearing loss 
 
3.5.2 Exclusion Criteria: 
• 
Non-native speaker of English 
  
3.6 
Outcome measures 
3.6.1 Primary outcome 
3.6.1.1 Glasgow Hearing Aid Benefit Profile (GHABP) 
The 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 score 
ranges from 0 (no benefit) to 5 (lots of benefit). The score at 1-week, 6-week and 12-week post 
intervention is the primary outcome. Participants will complete this questionnaire at 1-week, 6-week, 
and 12-week post-intervention based on their experience with the study device. 
 
3.6.2 Secondary outcomes 
3.6.2.1 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 100 (more handicap). Participants will complete this 
questionnaire at 1-week, 6-week, and 12-week post-intervention based on their experience with the 
study device. 
 
3.6.2.2 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). Participants will complete this 
questionnaire at 1-week, 6-week, and 12-week post-intervention based on their experience with the 
study device. 
 
3.6.2.3 Willingness-to-pay (WTP) 
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. Participants will 
complete this questionnaire at 6-week, and 12-week post-intervention based on their experience with 
the study device. 
 

 
4 
3.6.2.4 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). Participants will complete this questionnaire at 1-
week, 6-week, and 12-week post-intervention based on their experience with the study device. 
 
3.6.2.5 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). Participants will complete this 
questionnaire at 1-week, 6-week, and 12-week post-intervention based on their experience with the 
study device. 
 
3.6.2.6 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). Participants will complete this 
test in the laboratory at 1-week, 6-week, and 12-week post-intervention with the study device. 
 
3.7 
Statistical analysis 
Because this is an exploratory study, no statistical analysis will be conducted.  
 
3.8 
Adverse events  
Adverse events will be monitored for each subject during their participation in the study, which 
averaged 12 weeks from the time the participants entered the study.