Authored by Rohit Mehrotra*
Abstract
Introduction: This study is a comparitive study between oticon Digisonic and Cochlear limited implants outcomes in 200 implant surgeries at late Dr S N Mehrotra charitable ENT foundation between 2016 to 2019.
Material and methods: 100 children of Digisonic and 100 of Cochlear Ltd who were implanted between 2016-2019 in Mehrotra ENT hospital, were included in the study. Outcomes of all the implanted children in both groups were analyzed. Scoring system for auditory performance, speech rehabilitation and quality of life were also taken into account for every child implanted. Results of both groups were compared.
Results: Highest CAP level attained in cochlear group was 10 whereas in Digisonic group 5. 23% in Cochlear group had CAP level of 5 and above compared to only 1% in Digisonic group. 88% of children in Cochlear group had highest SIR of 5 and 6 compared to 75% in Digisonic group. 87% of cochlear group had GCBI index greater than 80(maximum benefit) compared to 41% of Digisonic group. Only 1% belongs to mild benefit in Cochlear group whereas in Digisonic 29% in minimal benefit group.
Conclusion: Cochlear LTD group results were better when compared to Digisonic group in terms of hearing, speech and quality of life index. Digisonic implants had easier insertion. Cochlear proved to be better than Digisonic owing to superior hearing, speech and quality of life outcomes.
Keywords: Oticon digisonic; Cochlear limited; Electrode insertion; Outcomes
Introduction
Oticon is a hearing aid manufacturer based in Copenhagen, Denmark. It was founded in 1904 by Hans Demant, whose wife was hearing impaired. The company uses a management style known as “Spaghetti Organization” [1,2]. introduced by Lars Kolind [3-5]. The highly reliable cochlear implants in the Digisonic®SP range enable surgeons to select the most appropriate solution for each patient, taking into account their cochlear anatomy, auditory nerve and any residual hearing.
The Digisonic®SP implant houses a magnet and receiver within a single unit made of ceramic and titanium. This monobloc structure makes surgery easier because the implant can be simply slid under the skin and fixed into place using two titanium screws [6]. Furthermore, as the procedure is minimally invasive, patients can benefit from faster healing times and greater implant stability. Once in place, the casing’s convex shape is designed to absorb any shock waves for greater impact resistance. The Digisonic®SP cochlear implant range can be used with two different proven electrode arrays to suit the patient’s anatomy.
The 20 stimulating electrodes of the Digisonic®SP implant allow a very precise stimulation of the auditive nerve at an optimal speed of a maximum 24,000 pulses per second. This stimulation speed is intended to transmit essential information to you while reducing the energy consumption of the implant. As a result, the behind the ear that is paired with the Digisonic®SP implant consumes only two Zinc-Air batteries for a battery life of 3 to 4 days (it is also possible to use 2 rechargeable batteries). Simple and stable placement of the implant, thanks to a unique system of fixation. The Digisonic®SP is the first monobloc implant that integrates a fixation system with 2 titanium self-tapping micro-screws (1); it does not require drilling of the bone or a suture to position the implant. The flexibility of the silicon mounting tabs allows perfect adjustment to the shape of the head. According to a study [7] conducted on the screw fixation system, the unique surgical technique of the Digisonic®SP implant significantly reduces operating time.
Thanks to the deep insertion (26mm) of the electrode array into the cochlea, the 20 platinum-iridium electrodes of the Digisonic®SP allow stimulation of the complete sound spectrum. Due to the structure of its memory shape and its optimal dimensions, the Digisonic®SP electrode array is recognized by many professionals as the simplest to handle, even in case of anatomic complications. The ease of use of the electrode array of the Digisonic®SP implant favors a natural positioning inside the cochlea.
Cochlear is a medical device company that designs, manufactures and supplies the Nucleus cochlear implant, the Hybrid electro-acoustic implant and the Baha bone conduction implant [8]. Nucleus is a system combining an electrical simulation device that is surgically implanted behind a patient’s ear, a processor that captures sounds, and an electrode array that relays the sounds to the brain [8,9]. It is a direct descendant of the original cochlear implants, also known as Nucleus, developed by Dr Graeme Clark in Melbourne during the 1970s [10]. Nucleus was the first cochlear implant to be approved by the U.S. Food and Drug Administration [11].
Unique features of Cochlear’s electrode portfolio include:
1) 22 active contacts for optimal hearing zone coverage [12], 10 inactive electrodes designed to be inserted closest to the hearing nerve for your best hearing performance [8,10].
2) Best long-term implant reliability record in the industry [13-15]. Electrode placement is critical to hearing performance
Cochlear’s electrodes are intended to be placed where hearing nerve stimulation is most effective. In order to benefit from the full range of sound, the area closest to the hearing nerve tends to be stimulated [9,16]. This area is known as the hearing zone. Clinical research shows that deeper insertion beyond the hearing zone can be associated with deterioration in performance due to pitch confusion at the tip of the cochlea as well as damage to the delicate cochlear structures [9,11]. Insertion depth along with the most active sequential contacts in the industry-22 electrodes [12]-help provide access to the full spectrum of sound and a richer hearing experience. This study is a comparitive study between Oticon Digisonic and Cochlear limited implants outcomes in 200 implant surgeries at late Dr S N Mehrotra charitable ENT foundation between 2016 to 2019.
Material and Methods
Study was carried out at late Dr S N Mehrotra Charitable ENT foundation from 2016 to 2019. 100 children implanted with Digisonic implants and 100 implanted with Cochlear implants were taken into consideration. Study was done by collecting data through fully completed clinical records and information regarding present performance of implantees from our team. The discussion also includes feedback from rehabilitation team about performance of each implantee, the duration at which patients attained speech abilities and reach the respective categories of CAP and SIR score and their GCBI index. The following inclusion criteria were applied to all the selected subjects in the study.
Inclusion criteria
a) Children with bilateral severe to profound sensori-neural hearing loss.
b) had hearing aid trial for minimum of 3 months
c) psychological assessment was normal.
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