Clinical Survey of Oticon Medical Healing Cap

Conductive Hearing Loss Clinical Trial

Official title:

C51 - Clinical Survey of Oticon Medical Healing Cap

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274129
• Other study ID #: C51
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: November 23, 2017
• Start date: July 2014
• Est. completion date: April 19, 2016

Study information

• Verified date: November 2017
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 19, 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients eligible for treatment with a bone anchored hearing aid

• 18 years or older

Exclusion Criteria:

• Inability to participate in follow-up

• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Mixed Hearing Loss
• Unilateral Partial Deafness

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

Locations

Country	Name	City	State
Denmark	Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital	Aalborg
Denmark	Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet	Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical time	Time taken to perform the surgery	Recorded at surgery visit
Other	Surgical complications	Any complications during and after surgery	At the surgical visit
Other	Surgical complications	Any complications during and after surgery	At time of surgical follow up visit (visit window of 7-14 days after surgery)
Other	Implant stability		Duration of study (12 months of enrollment)
Other	Use of Healing cap II	Ease of use of Healing cap II and effect on surgical dressing	At the surgical visit
Other	Use of Healing cap II	Ease of use of Healing cap II and effect on surgical dressing	At time of surgical follow up visit (visit window of 7-14 days after surgery)
Other	Skin healing at first follow-up visit		At time of surgical follow up visit (visit window of 7-14 days after surgery)
Other	Pain and numbness		Duration of study (12 months of enrollment)
Other	Time of fitting and type of sound processor		Duration of study (12 months of enrollment)
Primary	Skin reactions according to Holgers	Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.	At time of sugical follow up visit (visit window of 7-14 days after surgery)
Secondary	Fitting of sound processor at surgical follow-up visit	Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.	At time of surgical follow up visit (visit window of 7-14 days after surgery)