Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
8 participants
OBSERVATIONAL
2017-04-12
2017-04-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
NCT01264510
Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
NCT02722330
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
NCT04006132
Adhear Bone Conduction System
NCT03533686
Immediate Loading of Bone Anchored Hearing Devices
NCT04611698
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The information collected in this study may lead to improved evaluation of patients considering BAHA implantation and expanded treatment options for new and existing BAHA users. Primary outcome measures will include hearing threshold and speech perception measures. All devices are commercially available and FDA approved.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort
Hearing and speech tests will be performed on the subject and repeated to compare results obtained using their current BAHA processor against results using super-power BAHA processor.
super-power BAHA processor
The super-power BAHA processor will be provided for use at the study visit only to run different types of hearing tests, speech understanding tests in quiet, and speech understanding tests in noise. The same tests will be performed with the use of the subject's current BAHA processor for comparison.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
super-power BAHA processor
The super-power BAHA processor will be provided for use at the study visit only to run different types of hearing tests, speech understanding tests in quiet, and speech understanding tests in noise. The same tests will be performed with the use of the subject's current BAHA processor for comparison.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* meet candidacy criteria for a high gain super-power processor with a fitting range up to 65 dB
* native English speaker
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hillary A Snapp
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hillary Snapp, AuD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Department of Otolaryngology
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Arehart KH, Kates JM, Anderson MC, Harvey LO Jr. Effects of noise and distortion on speech quality judgments in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2007 Aug;122(2):1150-64. doi: 10.1121/1.2754061.
Flynn MC, Sadeghi A, Halvarsson G. Baha solutions for patients with severe mixed hearing loss. Cochlear Implants Int. 2009;10 Suppl 1:43-7. doi: 10.1179/cim.2009.10.Supplement-1.43.
Gantz BJ, Turner C, Gfeller KE, Lowder MW. Preservation of hearing in cochlear implant surgery: advantages of combined electrical and acoustical speech processing. Laryngoscope. 2005 May;115(5):796-802. doi: 10.1097/01.MLG.0000157695.07536.D2.
Yu JK, Wong LL, Tsang WS, Tong MC. A tutorial on implantable hearing amplification options for adults with unilateral microtia and atresia. Biomed Res Int. 2014;2014:703256. doi: 10.1155/2014/703256. Epub 2014 Jun 2.
Norman, J. (2015). Review of fitting ranges. Cochlear Bone Anchored Solutions AB. D773528
Rubinstein JT, Parkinson WS, Tyler RS, Gantz BJ. Residual speech recognition and cochlear implant performance: effects of implantation criteria. Am J Otol. 1999 Jul;20(4):445-52.
Verhaegen VJ, Mulder JJ, Mylanus EA, Cremers CW, Snik AF. Profound mixed hearing loss: bone-anchored hearing aid system or cochlear implant? Ann Otol Rhinol Laryngol. 2009 Oct;118(10):693-7. doi: 10.1177/000348940911801002.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20170083
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.