Hearing ImpairmentPhase 1NCT00582946
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
A Phase 1 study testing Hearing Aid in people with Hearing Impairment, run by EarLens Corporation at 1 site in United States.
Trial summary
Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- 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 siteUnited States
- Study dates
- May 2006to Dec 2009
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hearing loss less than 60 dB at any frequency, no conductive hearing loss
Who cannot join
- Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Ear Lens Corporation
Redwood City, California, 94063
About this study
Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.
- Conditions
- Hearing Impairment
- Being tested
- Hearing Aid
- Keywords
- Hearing Loss, Eardrum, Transducer, Hearing in Noise
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing AidDevice
Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Contact Hearing Aid | Experimental | Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months. Receives: Device: Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Effective Sound Pressure Level (MEPO)
A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarLens Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Suzy Levy, Ph.D., EarLens Corporation
- Investigators
- Sunil Puria, Principal investigator, Ear Lens Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582946
- Sponsor's protocol ID
- R43DC008499-01
- Other IDs
- R44DC008499
- Status last verified
- Sep 2016
- First submitted
- 19 Dec 2007
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Please see publication for summary results.
Publications
Perkins R, Fay JP, Rucker P, Rosen M, Olson L, Puria S. The EarLens system: new sound transduction methods. Hear Res. 2010 May;263(1-2):104-13. doi: 10.1016/j.heares.2010.01.012. Epub 2010 Jan 29.
PubMed 20116419
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
- ClinicalTrials.gov ID
- NCT00582946
- Acronym / sponsor ID
- R43DC008499-01
- Conditions
- Hearing Impairment
- Keywords
- Hearing Loss, Eardrum, Transducer, Hearing in Noise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EarLens CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- May 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 3 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Contact Hearing Aid | Experimental | Device: Hearing AidSubjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hearing loss less than 60 dB at any frequency, no conductive hearing loss
Key exclusion criteria (1 listed)
- Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss
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 |
|---|---|---|
| Hearing AidSubjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. | Device | Magnetic Contact Hearing Aid |
Primary outcome
Maximum Effective Sound Pressure Level (MEPO)
Time frame: 1 month
A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20116419Perkins R, Fay JP, Rucker P, Rosen M, Olson L, Puria S. The EarLens system: new sound transduction methods. Hear Res. 2010 May;263(1-2):104-13. doi: 10.1016/j.heares.2010.01.012. Epub 2010 Jan 29.
- Electromagnetic EarLens system published in Hearing ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No. Please see publication for summary results.
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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.
Sunil Puria principal investigator
Ear Lens Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hearing Aid in people with Hearing Impairment, run by EarLens Corporation 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 1 inclusion and 1 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 4 Nov 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2016). 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?
Maximum Effective Sound Pressure Level (MEPO) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00582946, which also lists 1 linked publication.
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 4 Nov 2016.