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Could not adequately recruit enough subjects to reach appropriate sample size
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| super-power BAHA processor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Threshold testing | Conventional 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 processor | 1 hour |
| Speech perception in noise | Speech perception in noise will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor | 1 hour |
| Speech perception in quiet | Word understanding will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Adult bone-anchored implant recipients who met candidacy criteria for a high gain super-power processor with a fitting range up to 65 dB.
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Snapp, AuD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Department of Otolaryngology | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17672661 | Background | 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. | |
| 19195004 | Background | 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. |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 15867642 | Background | 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. |
| 24991564 | Background | 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. |
| Background | Norman, J. (2015). Review of fitting ranges. Cochlear Bone Anchored Solutions AB. D773528 |
| 10431885 | Background | 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. |
| 19894395 | Background | 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. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |