ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT0311837520170083NCT03118375Super Power in BAIHearing Outcomes Using Super-power Processors in Bone Anchored Implant RecipientsUniversity of MiamiOtherNoNoYesNo
The purpose of this study is to assess the benefit of new super-power bone-anchored hearing
aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and
single-sided hearing loss when they are unable to use or receive limited benefit from
traditional hearing. Until recently, BAHAs were only recommended to people with up to a
moderate hearing loss. New super-power BAHA processors may be able to help people who
previously were not candidates for BAHAs or received limited benefit from them. The
information collected in this study may lead to improved evaluation of and expanded treatment
options for people considering BAHA. Different types of hearing tests will be used to compare
the devices.
The objective of this study is to assess the benefit of new super-power bone-anchored hearing
aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and
single-sided hearing loss when they were not receiving benefit from traditional hearing aids
or could not use them due to differences in their ears related to surgery or congenital
anomalies. Stronger super-power processors may be able to help individuals who previously did
not meet candidacy for BAHA. This study will evaluate how much benefit they are getting from
their current devices compared to new super-power devices.
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.
Terminated
Could not adequately recruit enough subjects to reach appropriate sample size
April 12, 2017April 29, 2017April 29, 2017ObservationalNoCohortProspectiveThreshold testing1 hourConventional hearing test will be performed. Sound field testing will be performed to establish aided thresholds using the individual's current BAHA processor and super power BAHA processorSpeech perception in noise1 hourSpeech perception in noise will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processorSpeech perception in quiet1 hourWord understanding will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor18Conductive and Sensorineural Hearing LossCohortHearing 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.Devicesuper-power BAHA processorThe 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.Cohort
Adult bone-anchored implant recipients who met candidacy criteria for a high gain
super-power processor with a fitting range up to 65 dB.
Non-Probability Sample
Inclusion Criteria:
- 18 years of age or older
- meet candidacy criteria for a high gain super-power processor with a fitting range up
to 65 dB
- native English speaker
Exclusion Criteria:
- do not meet inclusion criteria
All18 YearsN/ANoHillary Snapp, AuDPrincipal InvestigatorUniversity of MiamiUniversity of Miami Department of OtolaryngologyMiamiFlorida33136United StatesUnited StatesArehart 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: 10.1121/1.2754061.17672661Flynn 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-1.43.19195004Gantz 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.D2.15867642Yu 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 2.24991564Norman, J. (2015). Review of fitting ranges. Cochlear Bone Anchored Solutions AB. D773528Rubinstein 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):445-52.10431885Verhaegen 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: 10.1177/000348940911801002.19894395April 2023April 12, 2017April 12, 2017April 18, 2017April 25, 2023April 25, 2023April 27, 2023Principal InvestigatorUniversity of MiamiHillary A SnappAssistant ProfessorHearing LossHearing Loss, SensorineuralNo