Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
Severe to Profound Mixed Hearing LossThe purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810 Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability of the Codacs™ Test System.
Osia CPT Code Study
Conductive Hearing LossMixed Hearing LossTo evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor...
Deafness; Sensoneural Single SidedConductive Hearing Loss1 moreThe aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).
Clinical Performance of a New Implant System for Bone Conduction Hearing
Deafness; Sensoneural Single SidedConductive Hearing Loss1 moreTo study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
Bone Conduction DeafnessUnilateral Deafness2 moreThe objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive...
DeafnessHearing Loss4 moreTo demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment). To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
Clinical Survey of Different Abutment Topologies
Conductive Hearing LossUnilateral Partial Deafness1 moreThis study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.
Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
Bone Conduction DeafnessUnilateral Deafness2 moreThe objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
Evaluation of the Baha SoundArc in Pediatric Patients
Hearing LossConductive4 moreThe purpose of this study is to gather clinical performance data on the Baha SoundArc
Investigation of an Updated Bone-anchored Sound Processor
Hearing LossHearing Loss10 moreThe study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor. The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.