Bilateral Hearing Loss
Conditions
Keywords
Bone anchored hearing systems, BAHS, Bilateral benefit, Ponto 3 SuperPower, Minimum Audible Angle, Auditory working memory
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).
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.
Interventions
DEVICEFitting 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.
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The participants are blinded to the tested condition (unilateral vs bilateral)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Audible Angle test | 4 months | Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SWIR test | 4 months | Percentage of recalled words in the unilateral and bilateral conditions |
| SSQ12 | 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 |
Countries
United Kingdom
Outcome results
None listed