New York Eye & Ear Infirmary
New York, 10003, United States
NCT Number: NCT00201617
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
Looking for future studies?
Notify Me18 year–70 year
All sexes
Observational
New York, 10003, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
Hearing in Noise Test
Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
Consonant-nucleus-consonant speech-recognition test
Time frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA
Localization in sound field test
Time frame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA
Questionnaire
The New York Eye & Ear Infirmary
Other
Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05379231
Ear Diseases, Hearing Disorders
London, Ontario, Canada
View Trial DetailsNCT03807713
Bone Conduction Deafness, Ear Diseases
Nijmegen, Netherlands
View Trial DetailsNCT03281967
Bone Conduction Deafness, Ear Diseases
Nijmegen, Netherlands
View Trial DetailsNCT01715948
Ear Diseases, Hearing Disorders
View Trial Details