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Completed

NCT Number: NCT04006132

Evaluation of the Benefits of Bilateral Fitting in BAHS Users

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).

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Key information

Conditions

Bilateral Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Audiology Department, Nuffield House, University Hospitals Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fitting of Ponto 3 SuperPower

Device

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 outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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