An interventional study of Healing cap II in Conductive Hearing Loss, Mixed Hearing Loss and Unilateral Partial Deafness, sponsored by Oticon Medical. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-27.
Sponsored by Oticon Medical · Not applicable, Interventional, and Supportive care
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Single arm study using a new healing cap as intervention
Device: Healing cap II
Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery
Skin reactions according to Holgers
Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.
Time frame: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Fitting of sound processor at surgical follow-up visit
Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.
Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
Surgical time
Time taken to perform the surgery
Time frame: Recorded at surgery visit
Surgical complications
Any complications during and after surgery
Time frame: At the surgical visit
Surgical complications
Any complications during and after surgery
Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
Implant stability
Time frame: Duration of study (12 months of enrollment)
Use of Healing cap II
Ease of use of Healing cap II and effect on surgical dressing
Time frame: At the surgical visit
Use of Healing cap II
Ease of use of Healing cap II and effect on surgical dressing
Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
Skin healing at first follow-up visit
Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
Pain and numbness
Time frame: Duration of study (12 months of enrollment)
Time of fitting and type of sound processor
Time frame: Duration of study (12 months of enrollment)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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