Trial Outcomes & Findings for Quality Control of CE-Certified Phonak Hearing Aids - 2020_43 (NCT NCT04723173)

Last Updated: 2022-03-11

Results Overview

A listening effort scaling procedure ('ACALES'; Krueger et al, 2017) was performed with noise cancellation on and off. ACALES is adaptive, altering the signal-to-noise ratio (SNR) at which speech is presented. Therefore it is not a simple rating scale. For each stimulus, a rating (14-point scale ranging from 1='effortless' to 14= 'only noise') was given for how "effortful" it was following speech. This results in 2-D data: a list of presentation SNRs (different for each participant), and respective participant ratings. Given the format of this data, it cannot be summarized using standard descriptive statistics. We defined SNR as the dependent variable and fitted a linear mixed effects model, with the predictors: listening effort rating \& intervention (treating participants as a random factor), characterizing SNR over the entire rating scale. The values reported represent the estimated marginal means of SNR for each intervention, averaged across effort ratings \& participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

2 weeks

Results posted on

2022-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Study Population This was a crossover design, in which all participants undertook the same conditions. The conditions (different hearing aid settings) were completed in a randomized order during a single study appointment. Therefore the number starting each period will not match the number completing the previous period. The study started with 10 participants in total. Single tests (test period 2 and 3) started just with 9 participants, because there was 1 withdrawal. Test period 2 were completed with 1 participant less, than test period 3 started. That was possible, because the tests were independent and 1 participant was not able to perform the test is period 2, but was able to perform the test in period 3.
Measure of Detection Threshold (in dB) STARTED	10
Measure of Detection Threshold (in dB) Feature for Soft Sounds On	10
Measure of Detection Threshold (in dB) Feature for Soft Sounds Off	10
Measure of Detection Threshold (in dB) COMPLETED	10
Measure of Detection Threshold (in dB) NOT COMPLETED	0
Subjective Listening Effort Scaling STARTED	9
Subjective Listening Effort Scaling DNC on	9
Subjective Listening Effort Scaling DNC Off	9
Subjective Listening Effort Scaling COMPLETED	8
Subjective Listening Effort Scaling NOT COMPLETED	1
Subjective Ratings of Sound Samples STARTED	9
Subjective Ratings of Sound Samples DNC on	9
Subjective Ratings of Sound Samples DNC Off	9
Subjective Ratings of Sound Samples COMPLETED	9
Subjective Ratings of Sound Samples NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Population This was a crossover design, in which all participants undertook the same conditions. The conditions (different hearing aid settings) were completed in a randomized order during a single study appointment. Therefore the number starting each period will not match the number completing the previous period. The study started with 10 participants in total. Single tests (test period 2 and 3) started just with 9 participants, because there was 1 withdrawal. Test period 2 were completed with 1 participant less, than test period 3 started. That was possible, because the tests were independent and 1 participant was not able to perform the test is period 2, but was able to perform the test in period 3.
Subjective Listening Effort Scaling One participant was not able to perform the test as required by the study protocol.	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Population n=10 Participants This was a crossover design, in which all participants undertook the same conditions.
Age, Continuous	62.7 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment Switzerland	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: In total there were 8 participants, who performed this test. It was a crossover- design, so each participant completed both arms during a single appointment in a randomized order. 9 participants started the test, but 1 was not able to perform the test, so the procedure was stopped for this participant and no data was collected.

Outcome measures

Outcome measures
Measure	Noise Reduction on n=8 Participants The noise reduction is activated. The feature shall support the hearing aid user in noisy situations and shall reduce the listening effort in these special situations. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.	Noise Reduction Off n=8 Participants To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
Subjective Listening Effort Scaling	-2.276 SNR (dB) Interval -4.91 to 0.358	-0.917 SNR (dB) Interval -3.55 to 1.717

SECONDARY outcome

Timeframe: 4 weeks

Population: The test was done by 9 participants, but just the results of 8 participants could be used for the analysis. This is because technical limitations meant it was not possible to perform the test under both experimental conditions for one participant.

The secondary Outcome measure of this study contains 2 parts. This first part reported here was the evaluation of the sound quality. A comparison was made between speech and music audio excerpts either with or without gain being increased by the feedback manager. Subjective ratings of sound quality were made under both of these conditions for one speech and one music sample, using the following scale: Bad (1) - Poor (2) - Fair (3) - Good (4) - Excellent (5). Results were analyzed separately for the speech and music samples.

Outcome measures

Outcome measures
Measure	Noise Reduction on n=8 Participants The noise reduction is activated. The feature shall support the hearing aid user in noisy situations and shall reduce the listening effort in these special situations. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.	Noise Reduction Off n=8 Participants To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) Speech sample	4 score on a scale Standard Deviation 0.99	4 score on a scale Standard Deviation 1.16
Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) Music sample	3.5 score on a scale Standard Deviation 1.49	4 score on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 2 weeks

This outcome measure evaluated the ability to detect sounds in a quiet environment. A comparison was made between the feature under investigation being activated and deactivated. Participants were asked to change the level of a speech sample until they were just able to detect it. The ability will be measured by a detection threshold (in dB).

Outcome measures

Outcome measures
Measure	Noise Reduction on n=10 Participants The noise reduction is activated. The feature shall support the hearing aid user in noisy situations and shall reduce the listening effort in these special situations. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.	Noise Reduction Off n=10 Participants To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
Measure of Detection Threshold (in dB) for Soft Sounds	36.62 dB Standard Deviation 8.1	38.21 dB Standard Deviation 9.33

SECONDARY outcome

Timeframe: 2 week

Population: 9 participants completed this study period, but just the results of 8 participants could be used. This was because technical issues limited the reliability of the measures made for one participant. N.B. this test was independent from the other tests in the study. Therefore the results are not influenced by other test periods. The number of people included in the analysis described here relates only to this test.

The second part of this secondary Outcome measure was the evaluation of audible artefacts either with or without the available gain being increased by the feedback manager. The outcome was measured as a binary response (artefacts audible/ not audible). Participants had to indicate whether artefacts were audible under both of these conditions. The number of positive ratings (artefacts were audible) was counted.

Outcome measures

Outcome measures
Measure	Noise Reduction on n=8 Participants The noise reduction is activated. The feature shall support the hearing aid user in noisy situations and shall reduce the listening effort in these special situations. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.	Noise Reduction Off n=8 Participants To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature. Feature for noise reduction (on): The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. Feature for noise reduction (off): To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) speech sample	2 Participants	1 Participants
Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) music sample	1 Participants	1 Participants

Adverse Events

Events During the Test Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Events Prior to Test Period (After Screening Appointment and Signed Informed Consent Form)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Events During the Test Period n=9 participants at risk During the test period no Adverse Events, serious adverse events or other events occured.	Events Prior to Test Period (After Screening Appointment and Signed Informed Consent Form) n=9 participants at risk The adverse events of this study were not related to the investigational device or to a test of the study. Therefore we report the adverse events in one group instead of each individual condition. The occurred events were prior to a test / study appointment. The adverse events occurred after the screening appointment, but before any intervention. Therefore the adverse events cannot be attributed to any single study condition. As such we report adverse events here simply for the entire study cohort.
Eye disorders Eye problem prior to first appointment	0.00% 0/9 • 3.5 month	11.1% 1/9 • Number of events 1 • 3.5 month
Infections and infestations Ear infection	0.00% 0/9 • 3.5 month	11.1% 1/9 • Number of events 1 • 3.5 month

Additional Information

Bernhard Buschle

Sonova AG

Phone: +41 58 928 44 21

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place