Hearing Loss, Sensorineural
Conditions
Brief summary
Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.
Interventions
DEVICEReceiver-in-canal hearing instrument; Manufacturer A
Commercially available receiver-in-canal hearing instrument from manufacturer A
DEVICEReceiver-in-canal hearing instrument; Manufacturer B
Commercially available receiver-in-canal hearing instrument from manufacturer B
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Identifying information will be removed from the hearing instruments before fitting the participants. However, participants may be able to research hearing instruments and identify devices based on physical appearance.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Moderate to severe sensorineural hearing loss * Current hearing aid user
Exclusion criteria
* Lack of willingness to wear study devices for approximately one month * Inability to travel to study appointments or to complete questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | End of home trial 1 (Day 10 of study) | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). |
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B | End of home trial 2 (20 days after study start) | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). |
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | End of home trial 3 (30 days after study start) | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). |
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. | End of home trial 1 (Day 10 of study) | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. . |
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. | End of home trial 2 (Day 20 of study) | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. |
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. | End of home trial 3 (Day 30 of study) | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-B-A Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B | 17 |
| B-A-B Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B | 9 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | A-B-A | B-A-B | Total |
|---|---|---|---|
| Age, Continuous | 73.5 years | 67 years | 70.25 years |
| Mild to moderate severe sensorineural hearing loss, bilaterally | 17 participants | 9 participants | 26 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 0 participants | 9 participants | 9 participants |
| Region of Enrollment United States | 17 participants | 0 participants | 17 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Time frame: End of home trial 1 (Day 10 of study)
Population: Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-B-A | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | 7.16 score on a scale | Standard Deviation 0.46 |
| B-A-B | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | 7.12 score on a scale | Standard Deviation 0.85 |
Primary
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Time frame: End of home trial 2 (20 days after study start)
Population: Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure hearing aid B, and for arm B-A-B, the outcomes will measure hearing aid A
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-B-A | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B | 7.61 score on a scale | Standard Deviation 0.42 |
| B-A-B | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B | 6.70 score on a scale | Standard Deviation 0.98 |
Primary
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Time frame: End of home trial 3 (30 days after study start)
Population: Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-B-A | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | 7.28 score on a scale | Standard Deviation 0.51 |
| B-A-B | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | 7.52 score on a scale | Standard Deviation 0.95 |
Comparison: Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared.p-value: >0.05t-test, 2 sided
Comparison: Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared.p-value: <0.0167t-test, 2 sided
Primary
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. .
Time frame: End of home trial 1 (Day 10 of study)
Population: Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-B-A | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. | 3.94 score on a scale | Standard Deviation 0.59 |
| B-A-B | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. | 3.80 score on a scale | Standard Deviation 0.3 |
Primary
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Time frame: End of home trial 2 (Day 20 of study)
Population: Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure study set B, and for arm B-A-B, the outcomes will measure study set A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-B-A | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. | 4.24 score on a scale | Standard Deviation 0.54 |
| B-A-B | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. | 3.76 score on a scale | Standard Deviation 0.28 |
Primary
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Time frame: End of home trial 3 (Day 30 of study)
Population: Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-B-A | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. | 4.12 score on a scale | Standard Deviation 0.47 |
| B-A-B | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. | 3.99 score on a scale | Standard Deviation 0.21 |
Comparison: Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared.p-value: <0.01666667t-test, 2 sided
Comparison: Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared.p-value: <0.01666667t-test, 2 sided