Clinical trial NCT04006132: Evaluation of the Benefits of Bilateral Fitting in BAHS Users
Official title: Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Hearing Loss
Keywords: Bone anchored hearing systems
BAHS
Bilateral benefit
Ponto 3 SuperPower
Minimum Audible Angle
Auditory working memory
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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).

Primary outcomes:
measure: Minimum Audible Angle test
timeFrame: 4 months
Secondary outcomes:
measure: SWIR test
timeFrame: 4 months
measure: SSQ12
timeFrame: 4 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Audiology Department, Nuffield House, University Hospitals Birmingham
state: West Midlands
Study officials:
affiliation: University Hospitals Birmingham, United Kingdom
name: William Brassington
role: PRINCIPAL_INVESTIGATOR
References: