Clinical trial NCT03374787: Evaluation of Sound Processor for a Transcutaneous System
Official title: Single Center Evaluation of a Sound Processor for a Transcutaneous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Mixed Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
Collaborators: name: Sahlgrenska University Hospital
First posted: 2017-12-15
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.

Detailed description: Bone conduction hearing systems 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. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

Eligibility criteria: Inclusion Criteria:

* Subjects implanted with the Bridging Bone Conductor (BBC) implant
* Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
* Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
* Active user of the BCI SP

Exclusion Criteria:

* Inability to participate in follow-ups
* Unsuitable as judged by the principle investigator or the sub-investigator

Primary outcomes:
measure: Aided Thresholds Fusion-unaided PTA
timeFrame: 6 months
Secondary outcomes:
measure: Aided Thresholds Fusion-unaided
timeFrame: 6 months
measure: Aided Thresholds Fusion PTA4
timeFrame: Baseline, 1 and 6 month(s)
measure: Aided Thresholds Fusion
timeFrame: Baseline, 1 and 6 month(s)
measure: Aided Thresholds Fusion-BCI PTA4
timeFrame: 6 months
measure: Aided Thresholds Fusion-BCI
timeFrame: 6 months
measure: Speech Intelligibility Fusion-unaided %
timeFrame: 6 months
measure: Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR)
timeFrame: 6 months
measure: Speech Intelligibility Fusion %
timeFrame: Baseline, 1 and 6 month(s)
measure: Speech Intelligibility Fusion SNR
timeFrame: Baseline, 1 and 6 month(s)
measure: Speech Intelligibility Fusion-BCI %
timeFrame: 6 months
measure: Speech Intelligibility Fusion-BCI SNR
timeFrame: 6 months
measure: Magnet Strength
timeFrame: Baseline, 1 and 6 month(s)
measure: IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation
timeFrame: Baseline, 1 and 6 month(s)
measure: Subjective Evaluation
timeFrame: Baseline, 1 and 6 month(s)
measure: Subjective Evaluation SSQ
timeFrame: Baseline, 1 and 6 month(s)
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: ENT departement, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Måns Eeg Olofsson, MD
role: PRINCIPAL_INVESTIGATOR
References: