Hearing LossNCT05055453
MyPhonak App Junior Pediatric Usability and Benefit Investigation
A study testing MyPhonak Junior App and Phonak Sky hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Germany.
Trial summary
Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- MyPhonak Junior App and Phonak Sky hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 4 Oct 2021to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children and adolescents between the ages of 7 and 17 years old.
- bilateral mild to severe hearing loss
- experienced hearing aid users for 6+ months
Who cannot join
- any additional disabilities to the hearing impairment
- inability to complete the study procedures
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Mainz, HNO-Klinik
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: ESolutions Functions for Children and Young People With the myPhonak App
Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.
- Conditions
- Hearing Loss
- Being tested
- MyPhonak Junior App, Phonak Sky hearing aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPhonak Junior AppDevice
The app is an accessory to the hearing aids which allows the user to make adjustments to their hearing aid in real-time. The hearing aid does not require the use of the app, but the objective of this study is to evaluate the effects of the user adjustments made via the app on the participant's speech intelligibility with the hearing aid.
Phonak Sky hearing aidDevice
A Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Study Group | Experimental | Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE hearing aids and given access to the Phonak hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings. Receives: Device: MyPhonak Junior App; Device: Phonak Sky hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test
Target speech is presented from a speaker in front of participant while background noise is presented from 4 surrounding speakers. The level of noise is presented at 65 dB SPL (Sound Pressure Level),with target speech presented at variable levels, both louder and softer than the noise. The dB SNR is the level at which the participant can correctly repeat 50% of the words. A lower/negative dB SNR is better, indicating that 50% of the speech is understood when noise is louder than or close to the level of speech. This test was given in three, randomized conditions for each participant at two visits: 1) hearing aids in Automatic, 2) hearing aids in Automatic but Directionality and Noise Reduction customized by participant using the app (i.e. "preferred" settings), and 3) hearing aids in Automatic but with the Directionality set to lowest level 0, (i.e. omnidirectional), and Noise Reduction set to the highest level 10,or all the way on (i.e., "extreme").Results of both visits was averaged
Measured: Day 1 of study, repeated on Day 14 of study
Secondary outcomes (1)
Assessment of Hearing Situations in Children's Every Day Lives Questionnaire
A German-language questionnaire which asks student to rate their listening quality in different environments. Participants compared their listening quality with hearing aids alone versus hearing aids plus the app. Rating scale is from 1 to 5 with 1 = mostly easy and 5 = mostly difficult, so a lower score is better, however a rating of 0 = no change. Participants were given one copy of questionnaire to fill out during week 1 of home trial, and a second copy to fill out during week 2 of home trial. Results are reported separately for week 1 and week 2.
Measured: Completion of first home trial at day 7, and completion of second home trial at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start4 Oct 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne K Läßig, M.D, M.D., Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055453
- Sponsor's protocol ID
- SRF-85, Sonova 2020_15
- Status last verified
- Apr 2024
- First submitted
- 14 Sep 2021
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESolutions Functions for Children and Young People With the myPhonak App
- ClinicalTrials.gov ID
- NCT05055453
- Acronym / sponsor ID
- SRF-85, Sonova 2020_15
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Study Group | Experimental | Device: MyPhonak Junior App, Device: Phonak Sky hearing aidParticipants age 8-17 with bilateral hearing loss will be fit with Phonak BTE hearing aids and given access to the Phonak hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children and adolescents between the ages of 7 and 17 years old.
- bilateral mild to severe hearing loss
- experienced hearing aid users for 6+ months
Key exclusion criteria (2 listed)
- any additional disabilities to the hearing impairment
- inability to complete the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyPhonak Junior AppThe app is an accessory to the hearing aids which allows the user to make adjustments to their hearing aid in real-time. The hearing aid does not require the use of the app, but the objective of this study is to evaluate the effects of the user adjustments made via the app on the participant's speech intelligibility with the hearing aid. | Device | Experimental Study Group |
| Phonak Sky hearing aidA Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss. | Device | Experimental Study Group |
Primary outcome
dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test
Time frame: Day 1 of study, repeated on Day 14 of study
Target speech is presented from a speaker in front of participant while background noise is presented from 4 surrounding speakers. The level of noise is presented at 65 dB SPL (Sound Pressure Level),with target speech presented at variable levels, both louder and softer than the noise. The dB SNR is the level at which the participant can correctly repeat 50% of the words. A lower/negative dB SNR is better, indicating that 50% of the speech is understood when noise is louder than or close to the level of speech. This test was given in three, randomized conditions for each participant at two visits: 1) hearing aids in Automatic, 2) hearing aids in Automatic but Directionality and Noise Reduction customized by participant using the app (i.e. "preferred" settings), and 3) hearing aids in Automatic but with the Directionality set to lowest level 0, (i.e. omnidirectional), and Noise Reduction set to the highest level 10,or all the way on (i.e., "extreme").Results of both visits was averaged
1 secondary outcome
Assessment of Hearing Situations in Children's Every Day Lives Questionnaire
Time frame: Completion of first home trial at day 7, and completion of second home trial at day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K Läßig, M.D, M.D. principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPhonak Junior App and Phonak Sky hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test (time frame: Day 1 of study, repeated on Day 14 of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.