Trial Outcomes & Findings for Smartphone Enabled Hearing Study (NCT NCT05872035)
NCT ID: NCT05872035
Last Updated: 2024-10-29
Results Overview
The IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
Approximately 18-31 days upon enrollment
Results posted on
2024-10-29
Participant Flow
Participants were recruited from multiple sites where audiological services were provided.
All 118 enrolled participants were randomized into the study
Participant milestones
| Measure |
Self-Fit Settings
Amplification settings established by algorithm and further adjusted by participants per their preference
Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference
|
Pro-Fit Settings
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
59
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smartphone Enabled Hearing Study
Baseline characteristics by cohort
| Measure |
Self-Fit Settings
n=59 Participants
Amplification settings established by algorithm and further adjusted by participants per their preference
Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference
|
Pro-Fit Settings
n=59 Participants
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Subject Medical History with >10.0% Occurrence
Deafness bilateral
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Subject Medical History with >10.0% Occurrence
Hypertension
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Subject Medical History with >10.0% Occurrence
Hypoacusis
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Subject Medical History with >10.0% Occurrence
Tinnitus
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Four-Frequency Pure Tone Average Results-Full Analysis Set
15-25 dB HL (No Impairment)
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Four-Frequency Pure Tone Average Results-Full Analysis Set
26-40 dB HL (Mild Impairment)
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Four-Frequency Pure Tone Average Results-Full Analysis Set
41-60 dB HL (Moderate Impairment)
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 18-31 days upon enrollmentThe IOI-HA survey is a 7-item questionnaire that assesses the effectiveness of hearing aids. It was self-administered to each study participant one time at the third scheduled clinic visit approximately 18-31 days after enrollment. For each participant, the IOI-HA total score (which ranges from 7-35 where higher scores indicate a better outcome) was computed and the mean IOI-HA scores were compared between the Experimental and Reference Groups.
Outcome measures
| Measure |
Self-Fit Settings
n=59 Participants
Amplification settings established by algorithm and further adjusted by participants per their preference
Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference
|
Pro-Fit Settings
n=59 Participants
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
|
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results
|
25.5 score on a scale
Standard Deviation 3.03
|
26.6 score on a scale
Standard Deviation 3.63
|
Adverse Events
Self-Fit Settings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pro-Fit Settings
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Self-Fit Settings
n=59 participants at risk
Amplification settings established by algorithm and further adjusted by participants per their preference
Apple Software: Amplification settings established by algorithm and further adjusted by participants per their preference
|
Pro-Fit Settings
n=59 participants at risk
Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
by Audiologist: Amplification settings established by clinical reference and further adjusted by an audiologist per current best practice
|
|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/59 • Participants were evaluated by the PI and/or designee(s) at each of the three scheduled clinic visits from the time they signed the ICF until they completed the study (approximately 18-31 days after enrollment).
|
1.7%
1/59 • Number of events 1 • Participants were evaluated by the PI and/or designee(s) at each of the three scheduled clinic visits from the time they signed the ICF until they completed the study (approximately 18-31 days after enrollment).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/59 • Participants were evaluated by the PI and/or designee(s) at each of the three scheduled clinic visits from the time they signed the ICF until they completed the study (approximately 18-31 days after enrollment).
|
1.7%
1/59 • Number of events 1 • Participants were evaluated by the PI and/or designee(s) at each of the three scheduled clinic visits from the time they signed the ICF until they completed the study (approximately 18-31 days after enrollment).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place