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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ponto 3 SuperPower sound processor | Experimental | All patients will be fitted with two bone-anchored sound processors (Ponto 3 SuperPower), unilaterally and bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Audible Angle test | Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| SWIR test | Percentage of recalled words in the unilateral and bilateral conditions | 4 months |
| SSQ12 | 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Brassington | University Hospitals Birmingham, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Audiology Department, Nuffield House, University Hospitals Birmingham | Birmingham | West Midlands | B15 2TH | United Kingdom |
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| ID | Term |
|---|---|
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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The participants are blinded to the tested condition (unilateral vs bilateral)
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|
| 4 months |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |