Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental device: Noise reduction on | Experimental | The noise reduction is activated. The feature shall support the hearing aid user in noisy situation and shall reduce the listening effort in these special situations. |
|
| Experimental device: Noise reduction off | Active Comparator | To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feature for noise reduction (on) | Device | The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Listening Effort Scaling | 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova AG | Stäfa | Canton of Zurich | 8712 | Switzerland |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Measure of Detection Threshold (in dB) |
| |||||||||||||||||||
| Subjective Listening Effort Scaling |
| |||||||||||||||||||
| Subjective Ratings of Sound Samples |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Population | This was a crossover design, in which all participants undertook the same conditions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Listening Effort Scaling | 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. | 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. | Posted | Mean | 95% Confidence Interval | SNR (dB) | 2 weeks |
3.5 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Events During the Test Period | During the test period no Adverse Events, serious adverse events or other events occured. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye problem prior to first appointment | Eye disorders | Non-systematic Assessment | Prior to the first appointment, the participant informed that the first appointment is not possible, due to problems with the retina. This event was prior to the first study appointment and is not related to the study devices or study test procedure. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernhard Buschle | Sonova AG | +41 58 928 44 21 | bernhard.buschle@sonova.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2019 | Oct 15, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Feature for noise reduction (off) | Device | To show the advantage of the noise reduction feature there is a comparison without the feature necessary. |
|
| 4 weeks |
| Measure of Detection Threshold (in dB) for Soft Sounds | 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). | 2 weeks |
| Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) | 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. | 2 week |
| COMPLETED | This test compared the activated and deactivated feature for noisy situations. It was done in a single appointment and each participant performed randomized the test with both conditions. The reason for the smaller sample size (10 started the study, just 9 this test period) is that 1 participant left the study prior to the test and 1 participant started the test, but was not able to perform the test as the study protocol required. Nevertheless this participant completed the rest of the study. |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) | 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. | 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. | Posted | Median | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Measure of Detection Threshold (in dB) for Soft Sounds | 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). | Posted | Median | Standard Deviation | dB | 2 weeks |
|
|
|
| Secondary | Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) | 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. | 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. | Posted | Count of Participants | Participants | 2 week |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Events Prior to Test Period (After Screening Appointment and Signed Informed Consent Form) | 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. | 0 | 9 | 0 | 9 | 2 | 9 |
|
| Ear infection | Infections and infestations | Non-systematic Assessment | In the first appointment the investigator noted an infection of the ear channel and canceled the appointment. No test was done and no device was placed on the ear at this time. The doctor confirmed that the participant is able to continue the study. |
|
Not provided
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |