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Evaluation of the Benefits of Bilateral Fitting in BAHS Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04006132
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

Brief Summary:
The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).

Condition or disease Intervention/treatment Phase
Bilateral Hearing Loss Device: Fitting of Ponto 3 SuperPower Not Applicable

Detailed Description:
The patients included in this study are adult patients with a bilateral conductive or mixed hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored devices (BAHS). The study consists of two visits. At visit 1, the patients are fitted unilaterally and bilaterally with the investigational device (Ponto 3 SuperPower). After fitting, the patients perform a test of spatial resolution (minimum audible angle, visit 1) and an auditory working memory test (visit 2). These two outcome measures are conducted in the laboratory using the Ponto 3 SuperPower unilaterally and bilaterally. Additionally, the patients fill in a questionnaire (SSQ12) to report perceived performance in their everyday life with their own devices. This is a post market study and all products used are CE marked and used in clinical practice worldwide.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The participants are blinded to the tested condition (unilateral vs bilateral)
Primary Purpose: Basic Science
Official Title: Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : January 7, 2020
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: Ponto 3 SuperPower sound processor
All patients will be fitted with two bone-anchored sound processors (Ponto 3 SuperPower), unilaterally and bilaterally.
Device: Fitting of Ponto 3 SuperPower
Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting two bone-anchored sound processors (Ponto 3 SuperPower) to patients that are already bilaterally implanted with abutments.




Primary Outcome Measures :
  1. Minimum Audible Angle test [ Time Frame: 4 months ]
    Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions


Secondary Outcome Measures :
  1. SWIR test [ Time Frame: 4 months ]
    Percentage of recalled words in the unilateral and bilateral conditions

  2. SSQ12 [ Time Frame: 4 months ]
    Subjective performance as measured by Speech, Spatial and Qualities of Hearing questionnaire (SSQ); 12 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult BAHS users, minimum 18 years and maximum 75 years.
  • Native English speakers.
  • Patients that are already bilaterally implanted.
  • Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
  • Experience with bilateral Ponto of at least 6 months.
  • Patients that are using both their sound processors daily.
  • PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
  • If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
  • If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.

Exclusion Criteria:

  • Not deemed suited by the principal investigator.
  • If the physician assesses that the patient is not fit for trial participation at any stage.
  • Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
  • Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006132


Locations
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United Kingdom
Audiology Department, Nuffield House, University Hospitals Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
Oticon Medical
Investigators
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Principal Investigator: William Brassington University Hospitals Birmingham, United Kingdom

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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT04006132    
Other Study ID Numbers: C71
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Oticon Medical:
Bone anchored hearing systems
BAHS
Bilateral benefit
Ponto 3 SuperPower
Minimum Audible Angle
Auditory working memory
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms