An interventional study of hearing aid -novel program and hearing aid - standard program in Hearing Loss, sponsored by Sonova AG. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.
People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.
This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.
Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sonova AG is the lead sponsor of 89 studies on the registry; 6 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
Hearing loss within the fitting ranges of the products.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.
Device: hearing aid -novel program · Device: hearing aid - standard program
novel microphone configuration
standard microphone configuration
Overall preference for a specific microphone setting/configuration
Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')
Time frame: 20 minutes
Rating of awareness of background noise
Scale from 0-100 with descriptors ('not at all' to 'extremely aware')
Time frame: 20 minutes
Rating of Listening effort
Scale from 1 - 7 with descriptors ('not at all' to 'very')
Time frame: 20 minutes
Rating of annoyance of artefacts
Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')
Time frame: 20 minutes
Started Mar 2023 (actual). Primary completion is estimated for Oct 2023, 7 months after the start.
Of 125 industry-sponsored interventional studies with no phase under Hearing Loss, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 7 months is above that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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