Unilateral DeafnessNCT00201617
Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness
An observational study of Unilateral Deafness, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Deafness
- What is being tested?
- Bone-anchored hearing aid
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult-onset deafness
- Deafness is unilateral - complete or near complete
Who cannot join
- the presence of a developmental disorder or mental retardation;
- history of drug abuse;
- psychiatric disease;
- inability to follow instructions or to participate in follow-up appointments
- inability to use the BAHA
- lack of osseo-integration -
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye & Ear Infirmary
New York, New York, 10003
About this study
Official title: Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness
Read the detailed description
Limited studies have been done on the BAHA in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. The findings of the limited number of studies to date on the BAHA with single sided deafness demonstrate that the BAHA improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the BAHA to have at least satisfactory benefit. But conflicting findings have been obtained regarding whether the BAHA improves the ability to locate the source of a sound. Additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity.
This investigation will show whether the previously reported BAHA benefits at one month post BAHA sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post BAHA sound processor fitting. This long-term investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect on localization abilities.
Subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the BAHA.In order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.
- Conditions
- Unilateral Deafness
- Being tested
- Bone-anchored hearing aid
- Keywords
- Unilateral hearing loss, Unilateral deafness, Bone anchored hearing aid
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-anchored hearing aidDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | normal hearing sensitivity | |
| 2 | Unilateral deafness who are implanted with a Bone Anchored Hearing Aid Receives: Device: Bone-anchored hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
HINT score
Hearing in Noise Test
Measured: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
CNC score
Consonant-nucleus-consonant speech-recognition test
Measured: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
Localization
Localization in sound field test
Measured: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA
Secondary outcomes (1)
Abbreviated Profiles of Hearing Aid Benefit
Questionnaire
Measured: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral DeafnessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- The Jacob and Valeria Langeloth Foundation
- Investigators
- Christopher J Linstrom, MD, Principal investigator, New York Eye & Ear InfirmaryCarol A Silverman, PhD, MPH, Principal investigator, New York Eye & Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201617
- Sponsor's protocol ID
- 03.33
- Other IDs
- 000303
- Status last verified
- Apr 2015
- First submitted
- 12 Sep 2005
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
- ClinicalTrials.gov ID
- NCT00201617
- Acronym / sponsor ID
- 03.33
- Conditions
- Unilateral Deafness
- Keywords
- Unilateral hearing loss, Unilateral deafness, Bone anchored hearing aid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Collaborators
- The Jacob and Valeria Langeloth Foundation
- Study start
- Jul 2004
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness
Detailed description
Limited studies have been done on the BAHA in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. The findings of the limited number of studies to date on the BAHA with single sided deafness demonstrate that the BAHA improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the BAHA to have at least satisfactory benefit. But conflicting findings have been obtained regarding whether the BAHA improves the ability to locate the source of a sound. Additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity.
This investigation will show whether the previously reported BAHA benefits at one month post BAHA sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post BAHA sound processor fitting. This long-term investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect on localization abilities.
Subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the BAHA.In order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –normal hearing sensitivity |
| 2 | – | Device: Bone-anchored hearing aidUnilateral deafness who are implanted with a Bone Anchored Hearing Aid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult-onset deafness
- Deafness is unilateral - complete or near complete
Key exclusion criteria (6 listed)
- the presence of a developmental disorder or mental retardation;
- history of drug abuse;
- psychiatric disease;
- inability to follow instructions or to participate in follow-up appointments
- inability to use the BAHA
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 |
|---|---|---|
| Bone-anchored hearing aid | Device | 2 |
Primary outcome
HINT score
Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
Hearing in Noise Test
CNC score
Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
Consonant-nucleus-consonant speech-recognition test
Localization
Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA
Localization in sound field test
1 secondary outcome
Abbreviated Profiles of Hearing Aid Benefit
Time frame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Christopher J Linstrom, MD principal investigator
New York Eye & Ear Infirmary
Carol A Silverman, PhD, MPH principal investigator
New York Eye & Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Deafness, run by The New York Eye & Ear Infirmary 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 2 inclusion and 6 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 14 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HINT score (time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA). The study lists 3 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 14 Apr 2015.