Conductive Hearing Loss Clinical Trial
Official title:
Single Center Evaluation of a Sound Processor for a Transcutaneous System
NCT number | NCT03374787 |
Other study ID # | C58 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 15, 2017 |
Est. completion date | November 22, 2018 |
Verified date | April 2019 |
Source | Oticon Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 22, 2018 |
Est. primary completion date | November 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | ENT departement, Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Oticon Medical | Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aided thresholds Fusion-unaided PTA | Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) | 6 months | |
Secondary | Aided thresholds Fusion-unaided | 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 | 6 months | |
Secondary | Aided thresholds Fusion PTA4 | Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) | Baseline, 1 and 6 month(s) | |
Secondary | Aided thresholds Fusion | Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at | Baseline, 1 and 6 month(s) | |
Secondary | Aided thresholds Fusion-BCI PTA4 | Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4) | 6 months | |
Secondary | Aided thresholds Fusion-BCI | 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 | 6 months | |
Secondary | Speech intelligibility Fusion-unaided % | Difference between Fusion-aided and unaided speech intelligibility scores (in % correct) | 6 months | |
Secondary | Speech intelligibility Fusion-unaided signal to noise ratio (SNR) | Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR | 6 months | |
Secondary | Speech intelligibility Fusion % | Difference between Fusion-aided speech intelligibility scores (in % correct) | Baseline, 1 and 6 month(s) | |
Secondary | Speech intelligibility Fusion SNR | Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR | Baseline, 1 and 6 month(s) | |
Secondary | Speech intelligibility Fusion-BCI % | Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct) | 6 months | |
Secondary | Speech intelligibility Fusion-BCI SNR | Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR | 6 months | |
Secondary | Magnet strength | Difference in magnet strength measured on the patient's heads in Newton | Baseline, 1 and 6 month(s) | |
Secondary | IPS (Inflammation, Pain, Skin height/numbness) evaluation | Combined score of IPS 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) | Baseline, 1 and 6 month(s) | |
Secondary | Subjective evaluation | User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor | Baseline, 1 and 6 month(s) | |
Secondary | Subjective evaluation SSQ | Subjective performance as measured by Speech, Spatial and Quality (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect" | Baseline, 1 and 6 month(s) |
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