Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201617
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2005-09-12
Brief Title:
Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness
Sponsor:
The New York Eye Ear Infirmary
Organization:
The New York Eye Ear Infirmary
Study Overview
Official Title:
Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this 3-year prospective investigation is to examine the short-term and long-term 1 yearefficacy 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 BAHAIn 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
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 BAHAIn 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000303 | None | None | None |