Super Power in BAI

Hearing Outcomes Using Super-power Processors in Bone Anchored Implant Recipients

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.

Study Overview

• Status: Terminated
• Conditions: Conductive and Sensorineural Hearing Loss
• Intervention / Treatment: Device: super-power BAHA processor

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Department of Otolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult bone-anchored implant recipients who met candidacy criteria for a high gain super-power processor with a fitting range up to 65 dB.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hillary Snapp, AuD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): April 29, 2017
• Study Completion (Actual): April 29, 2017

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: 20170083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No