Evaluation of Sound Processor for a Transcutaneous System

Not Applicable

Completed

Conditions: Conductive Hearing Loss
Mixed Hearing Loss

Interventions: Device: Fusion Sound Processor

Registration Number: NCT03374787

Lead Sponsor: Oticon Medical

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fusion sound processor	Fusion Sound Processor	The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.

Primary Outcome Measures

Name	Time	Method
Aided Thresholds Fusion-unaided PTA	6 months	Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

Secondary Outcome Measures

Name	Time	Method
Aided Thresholds Fusion-unaided	6 months	Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz
Aided Thresholds Fusion PTA4	Baseline, 1 and 6 month(s)	Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)
Aided Thresholds Fusion	Baseline, 1 and 6 month(s)	Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at
Aided Thresholds Fusion-BCI PTA4	6 months	Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)
Aided Thresholds Fusion-BCI	6 months	Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz
Speech Intelligibility Fusion-unaided %	6 months	Difference between Fusion-aided and unaided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.
Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR)	6 months	Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.
Speech Intelligibility Fusion %	Baseline, 1 and 6 month(s)	Difference between Fusion-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.
Speech Intelligibility Fusion SNR	Baseline, 1 and 6 month(s)	Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.
Speech Intelligibility Fusion-BCI %	6 months	Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used
Speech Intelligibility Fusion-BCI SNR	6 months	Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.
Magnet Strength	Baseline, 1 and 6 month(s)	Difference in magnet strength measured on the patient's heads in Newton
IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation	Baseline, 1 and 6 month(s)	Combined score of IInflammation, Pain and Skin height/numbness scale evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales). Lower score means better performance
Subjective Evaluation	Baseline, 1 and 6 month(s)	User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor. The scale used is a scale with descriptive values.
Subjective Evaluation SSQ	Baseline, 1 and 6 month(s)	Subjective performance as measured by Speech, Spatial and Qualities of hearing (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". A higher score means better performance.

Trial Locations

Locations (1): ENT departement, Sahlgrenska University Hospital
🇸🇪
Gothenburg, Sweden
ENT departement, Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden