Hearing LossNCT05468918
Real World Perspectives on Advancements in Hearing Aid Technology
A study testing Phonak Audeo previous generation hearing aids and Phonak Audeo Lumity hearing aids in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Audeo previous generation hearing aids and Phonak Audeo Lumity hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 26 Oct 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate sensorineural hearing loss
- Experienced hearing aid user
- Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
- Smartphone user for receiving study alerts
Who cannot join
- Cognitive impairment
- Not willing to wear hearing aid
Trial locations and contacts
1 site in 1 country.
United States1 site
Phonak Audiology Research Center
Aurora, Illinois, 60504
About this study
This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.
Read the detailed description
Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.
This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.
- Conditions
- Hearing Loss
- Being tested
- Phonak Audeo previous generation hearing aids, Phonak Audeo Lumity hearing aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonak Audeo previous generation hearing aidsDevice
Receiver-in-canal (RIC) hearing aids with universal earpieces
Phonak Audeo Lumity hearing aidsDevice
Receiver-in-canal (RIC) hearing aids with universal earpieces
| Study group | Role | What they receive |
|---|---|---|
| Participants tested with comparator devices first, then Audeo Lumity devices | Experimental | All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices. Receives: Device: Phonak Audeo previous generation hearing aids; Device: Phonak Audeo Lumity hearing aids |
| Participants who were tested with Audeo Lumity first, then comparator devices | Experimental | All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices. Receives: Device: Phonak Audeo previous generation hearing aids; Device: Phonak Audeo Lumity hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in Noise Test
A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.
Measured: Day 1 of study
Subjective Perception of Listening Effort
Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.
Measured: Day 1 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start18 Jul 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468918
- Sponsor's protocol ID
- SRF-2855
- Status last verified
- Aug 2023
- First submitted
- 18 Jul 2022
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Perspectives on Advancements in Hearing Aid Technology
- ClinicalTrials.gov ID
- NCT05468918
- Acronym / sponsor ID
- SRF-2855
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Posted 22 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.
Detailed description
Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.
This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants tested with comparator devices first, then Audeo Lumity devices | Experimental | Device: Phonak Audeo previous generation hearing aids, Device: Phonak Audeo Lumity hearing aidsAll participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices. |
| Participants who were tested with Audeo Lumity first, then comparator devices | Experimental | Device: Phonak Audeo previous generation hearing aids, Device: Phonak Audeo Lumity hearing aidsAll participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate sensorineural hearing loss
- Experienced hearing aid user
- Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
- Smartphone user for receiving study alerts
Key exclusion criteria (2 listed)
- Cognitive impairment
- Not willing to wear hearing aid
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 |
|---|---|---|
| Phonak Audeo previous generation hearing aidsReceiver-in-canal (RIC) hearing aids with universal earpieces | Device | Participants tested with comparator devices first, then Audeo Lumity devices, Participants who were tested with Audeo Lumity first, then comparator devices |
| Phonak Audeo Lumity hearing aidsReceiver-in-canal (RIC) hearing aids with universal earpieces | Device | Participants tested with comparator devices first, then Audeo Lumity devices, Participants who were tested with Audeo Lumity first, then comparator devices |
Primary outcome
Speech in Noise Test
Time frame: Day 1 of study
A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.
Subjective Perception of Listening Effort
Time frame: Day 1 of study
Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonak Audeo previous generation hearing aids and Phonak Audeo Lumity hearing aids in people with Hearing Loss, run by Sonova AG at 1 site in United States.
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 4 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 22 Aug 2023. 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 United States. 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 22 Aug 2023). 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?
Speech in Noise Test (time frame: Day 1 of study). The study lists 2 primary outcomes in all. 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 22 Aug 2023.