Hearing Loss
Conditions
Brief summary
This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit.
Detailed description
Participants will be fit with hearing aids using two different fitting methods (fitting A and fitting B). The order of the fitting will be randomized such that half of the participants will start out with fitting A and half of the participants will start out with fitting B. All participants will undergo baseline speech testing and answer a questionnaire about their experiences in daily life without hearing aids. All participants will use devices for a period of 1-2 weeks in their daily lives. After this first home trial, participants will return to the clinic where they will answer questionnaires regarding their experience with the devices. They will also perform aided speech testing. They will then be given devices with the second fitting method and will wear devices for a period of 1-2 weeks in their daily lives. Following the second home trial, all participants will return to the clinic to answer the same questionnaire that was given after home trial #1, and complete aided speech testing. The results for each of the two fitting methods will be analyzed.
Interventions
DEVICEExperimental hearing aid
This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.
Sponsors
University of South Florida
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subjects will be fit with two sets of identical devices. One set will be programmed to fitting method A and one set will be programmed to fitting method B. Subjects will be blinded as to which set they are sent on a home trial with. Outcomes will be assessed at return visits by a second sub-investigator who does not know which devices the subject is wearing.
Intervention model description
This study is a prospective, repeated measures, within-subject, cross over design. Subjects will be assigned in random order to the two fitting methods. Subjects will be blinded as to which fitting method they are using during the home trials.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate bilateral hearing loss * First time (new) hearing aid users or experienced hearing aid users * Ability to use a smartphone * Fluent in English; ability to read and write in English * Willing and able to provide informed consent
Exclusion criteria
* Self reported ear-related pathology including otorrhea within 90 days, dizziness, sudden onset or worsening of hearing loss within 90 days, visible deformity of the ear, otalgia * Unilateral hearing loss * Chronic, severe tinnitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study | A validated questionnaire that assesses the subjective benefit of hearing aids in daily life. Participants rate their difficulty hearing in different situations, going from Always (99%), Almost Always (87%), Generally (75%), Half the time (50%), Occasionally (25%), Seldom (12%) or Never (1%). For example, the participant may choose Always to the statement When I am having a quiet conversation with a friend, I have difficulty understanding. The questions are categorized into 4 different sub-scales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness. The global score is calculated by taking the average of three of the subscales: EC, BN, and RV. The scores can range from 1% to 99%. Global Benefit is calculated by subtracting the aided global score from the unaided global score. The mean global benefit is calculated for each fitting method, and a higher benefit score is better. Result reported is the global benefit score for each fitting method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss | Day 1 (unaided/baseline testing) of study, day 14 (aided testing with first fitting method) and day 28 (aided testing with second fitting method) of study | Objective speech in noise testing calculates the level in which speech stimuli needs to be louder than background noise for the participant to correctly repeat back 50% of key words. A lower score/dB level is better. For example, a score of 2 dB means that the speech needs to be louder than the background noise by 2 dB in order for the individual to correctly repeat 50% of the words. However, a score of 10 dB means that the speech needs to be 10 dB louder than the background noise for the individual to correctly repeat 50% of the words. This test is done in the unaided condition, as well as with both aided conditions (fitting method A and fitting method B) and the benefit score for each fitting method is determined by subtracting the aided dB SNR score from the unaided dB SNR score. A higher benefit score is better. |
Countries
United States
Participant flow
Pre-assignment details
After the initial appointment in which participants were fit with both fitting methods, there was a wash out period of 1-5 days. After the wash-out period, participants returned to the site at which time they were assigned/randomized into an arm of the study. This wash-out period provided time to reduce the possibility that participants would remember how each fitting method sounded to them, and therefore reduce the chance for bias.
Participants by arm
| Arm | Count |
|---|---|
| Fitting Method A First, Then Fitting Method B Participants will be fit with a set of hearing devices that are programmed to fitting method A first. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm.
Following a home trial with fitting method A, participants will then be fit with a set of hearing devices that are programmed to fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm.
Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application. | 23 |
| Fitting Method B First, Then Fitting Method A Participants will be fit with a set of hearing aids that are programmed using fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm.
Following a home trial with fitting method B, participants will then be fit with a set of hearing devices that are programmed to fitting method A. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm.
Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application. | 21 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Fitting Method A First, Then Fitting Method B | Fitting Method B First, Then Fitting Method A | Total |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 11.68 | 68 years STANDARD_DEVIATION 7.94 | 68 years STANDARD_DEVIATION 9.96 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 1 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
Primary
Abbreviated Profile of Hearing Aid Benefit (APHAB)
A validated questionnaire that assesses the subjective benefit of hearing aids in daily life. Participants rate their difficulty hearing in different situations, going from Always (99%), Almost Always (87%), Generally (75%), Half the time (50%), Occasionally (25%), Seldom (12%) or Never (1%). For example, the participant may choose Always to the statement When I am having a quiet conversation with a friend, I have difficulty understanding. The questions are categorized into 4 different sub-scales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness. The global score is calculated by taking the average of three of the subscales: EC, BN, and RV. The scores can range from 1% to 99%. Global Benefit is calculated by subtracting the aided global score from the unaided global score. The mean global benefit is calculated for each fitting method, and a higher benefit score is better. Result reported is the global benefit score for each fitting method.
Time frame: Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitting Method A | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 0.099 score on a scale | Standard Deviation 0.1695 |
| Fitting Method B | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 0.106 score on a scale | Standard Deviation 0.1309 |
p-value: 0.806Mixed Models Analysis
Secondary
Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss
Objective speech in noise testing calculates the level in which speech stimuli needs to be louder than background noise for the participant to correctly repeat back 50% of key words. A lower score/dB level is better. For example, a score of 2 dB means that the speech needs to be louder than the background noise by 2 dB in order for the individual to correctly repeat 50% of the words. However, a score of 10 dB means that the speech needs to be 10 dB louder than the background noise for the individual to correctly repeat 50% of the words. This test is done in the unaided condition, as well as with both aided conditions (fitting method A and fitting method B) and the benefit score for each fitting method is determined by subtracting the aided dB SNR score from the unaided dB SNR score. A higher benefit score is better.
Time frame: Day 1 (unaided/baseline testing) of study, day 14 (aided testing with first fitting method) and day 28 (aided testing with second fitting method) of study
Population: All participants who completed unaided/baseline speech in noise testing and aided speech in noise testing with both fitting methods so that the aided benefit score could be calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitting Method A | Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss | -0.131 decibels (dB) | Standard Deviation 1.81 |
| Fitting Method B | Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss | -0.069 decibels (dB) | Standard Deviation 1.54 |
p-value: 0.889Mixed Models Analysis