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Clinical Publications with the Ponto system

Implantation of Bone-Anchored Hearing Devices Through a Minimal Skin Punch Incision Versus the Epidermal Flap Technique.
Dumon T, Wegner I, Sperling N, Grolman W. January 2017
The study compares two techniques for implantation of percutaneous bone-anchored hearing devices; minimal skin punch incision without additional skin incision and soft tissue reduction (punch group) and the epidermal flap technique with soft tissue reduction (dermatome group). Sixty-five implants were placed in the punch group and 155 in the dermatome group. Using the punch technique shortened the duration of surgery and improved postoperative appearance, while preserving a good skin tolerance. The percentage of normal to moderate skin reactions, by Holgers classification, was higher in the punch group (90%) than in the dermatome group (84%). The need for revision surgeries due to skin issues was drastically reduced. The rate of implant loss, although low, was higher with longer than with shorter abutments, and could be the main drawback of longer abutments.

Short-term results from seventy-six patients receiving a bone anchored hearing implant installed with a novel minimally invasive surgery technique.
Johansson M, Stokroos RJ, Banga R, Hol MK, Mylanus EA, Savage Jones H, Tysome JR, Vannucchi P, Hof JR, Brunings JW, van Tongeren J, Lutgert RW, Banerjee A, Windfuhr JP, Caruso A, Giannuzzi AL, Bordin S, Hanif J, Schart-Morén N, Singam S, Jonhede S, Holmberg M, Cremers CW, Hultcrantz M. December 2016
The publication presents the results from a multicenter service evaluation using the wide Ponto implant installed using first generation Minimally Invasive Ponto Surgery (MIPS) components. Minimally invasive Ponto Surgery is a refinement of tissue preservation and punch only surgeries. In the MIPS technique, the drilling procedure is performed through a cannula and the implant installation is completed through the incision created by a 5 mm biopsy punch. Seventy-seven implants were installed in 76 adult patients. After a follow-up time of 20-49 weeks the evaluation of the system showed encouraging results with few intra-operative complications, short surgery time, excellent healing and good short-term results regarding soft tissue reactions and implant survival. Based on the preliminary results, the MIPS instruments have been further improved and a further evaluation is in progress.

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial.
Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ. November 2016
The publication describes the study protocol of the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.

Bone anchored hearing implants without skin thinning: the Gruppo Otologico surgical and audiological experience
Caruso A, Giannuzzi AL, Sozzi V, Sanna M, Eur Arch Otorhinolaryngol. 2016 September 14
The study investigates the surgical and audiological outcomes of an installation of Ponto implants and abutments without tissue reduction.
Forty-nine patients, 18 years or older were included in the study. Data regarding surgical intervention, quality of life (GBI), skin and soft tissue reactions (Holgers grading system) and pain and numbness (VAS) was collected. Hearing performance (aided thresholds and speech recognition in noise) was recorded in 20 patients.
No implants were lost, skin, and soft tissue reactions were mild in 96 % of the all visits. Quality of life (GBI) generally improved in the aided condition compared to prior to implantation. Audiologically, 100 % of the 20 patients examined showed improvement of speech reception and sound field thresholds comparing aided to unaided. An average improvement of 33 dB on PTA was recorded.
The study, presenting data on a large population treated with tissue preservation and modern titanium implants, shows that this is a viable solution that results in few complications, high degree of predictability and good audiological results.

Wireless and acoustic hearing with bone-anchored hearing devices
Bosman AJ, Mylanus EA, Hol MK, Snik AF, Int J Audiol., May 2016
Nineteen subjects compared the Ponto Plus with Streamer to Ponto Pro. Laboratory test showed that equal input levels for acoustic and wireless inputs results in equal speech scores, showing a (near) equivalence for acoustic and wireless sound transmission with Ponto Pro and Ponto Plus. The default 9-dB difference between microphone and wireless input when using the telephone results in a substantial wireless benefit when using the telephone.
Subjectively ratings of sound quality, speech in quiet, and speech in noise were significantly higher (p <1%) for Ponto Plus with streamer compared to Ponto Pro when using landline phone, mobile phone and watching TV. Also the annoyance by ambient noise was strongly reduced when using the Streamer for mobile phone and watching TV over Ponto Pro.

Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft Tissue Preservation
den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Otology & Neurotology, March 2016
The publication accounts for the results of a prospective cohort study, using Ponto Wide implants, comparing treatment using linear incision with soft-tissue preservation vs standard linear incision with soft-tissue reduction. Twenty-five patients were enrolled in each group and the follow-up was six months, both clinical and audiological outcomes were included in the study. Tissue preservation resulted in better results on sensibility and shorter total surgery time. Soft-tissue reactions according to the Holgers classification were observed in seven patients in the tissue preservation group (7.5% of visits) and one in the tissue reduction group (0.6% of visits). All adverse reactions were resolved after local treatment. All sound processors were fitted three weeks after surgery. According the authors “The current good results suggest that loading at 3 weeks seems safe at short-term follow-up, also when using tissue preservation and longer abutments”. The authors conclude that tissue preservation compared with tissue reduction leads to a generally favorable clinical outcome, comparable audiology results, and significantly shorter surgery time.

Clinical Outcome of a Wide-diameter Bone-anchored Hearing Implant and a Surgical Technique With Tissue Preservation
Marius S. Mowinckel, Martin N. Møller, Kirsten N. Wielandt, and Søren Foghsgaard. Otology & Neurotology, March 2016
The objective of this study was to investigate the clinical outcome of a surgical technique with tissue preservation and Ponto Wide implants concerning postoperative complications, skin-reactions, implant loss, and implant stability. Twenty-four adult patients with normal skin quality participated and follow-up was done at ten days, six weeks, six months, and one year after surgery. The primary implant stability was good and a significant increase in ISQ (implant stability quotient) occurred during the first ten days. ISQ continued to be stable throughout the one-year observation period and no implants were lost. Skin and soft tissue reactions were few, no reaction (Holger grade 0) was observed in 88% of the follow-up examinations and no grade 4 reactions occurred. Pain and numbness were minimal.

Three-week loading of the 4.5 mm wide titanium implant in bone anchored hearing systems
Wazen JJ, Babu S , Daugherty J, Metrailer A. Am J Otolaryngol, March 2016
The purpose of this study was to assess implant stability, implant loss, adverse skin reactions and quality of life benefit following surgical implantation and three-week processor loading of the Oticon Medical Ponto Wide (4.5 mm) implant. Thirty adult patients 18 years or older were evaluated using a prospective multicenter design during a one-year follow-up time. The results show a positive linear trend in implant stability measures in all subjects over time. There were no implant losses and skin reactions were limited to grade 0 and 1 of the modified Holger's grading scale. The authors conclude that their findings confirm the safety and efficacy of early loading of the Oticon Medical 4.5 mm wide implant. Participants showed satisfaction with the earlier use of their processor and there were no added complications.

Punch and Drill: Implantation of Bone Anchored Hearing Device Through a Minimal Skin Punch Incision Versus Implantation With Dermatome and Soft Tissue Reduction
Dumon T, Medina M, Sperling NM., Ann Otol Rhinol Laryngol. September 2015
This publication compares two surgical techniques; implantation using dermatome and a punch-only technique without soft tissue reduction (not to be confused with the recently introduced MIPS technique). Of the 40 patients, 20 were allocated to the dermatome and punch-only group respectively. Six of the patients in the dermatome group, and 16 in the punch-only received Ponto implants (Oticon Medical).
The results showed that with the punch-only technique, the surgical time was shorter (15 vs 30 minutes) and the postoperative healing appeared better. The skin tolerance with the punch-only technique was at least as good as that obtained with the dermatome technique (85.7% vs 86%). There was a tendency for lower incidence of severe skin reactions in the punch group. In the punch group, the skin returned to normal, completely covered by hair around the implant.

Comparison of audiologic results and patient satisfaction for two osseointegrated bone conduction devices: results of a prospective study
Busch S., Giere T., Lenarz T., Maier H., Otology & Neurology, June 2015
This publication conducted at Hannover Medical Center presents results from a prospective, cross over designed, study comparing audiological objective and subjective outcome between Ponto Pro Power (Oticon Medical) and BP110 (Cochlear). Eleven test subjects with conductive or mixed hearing loss participated. Results from two questionnaires, APHAB and SSQ-C, showed an overall significant advantage for Ponto Pro Power compared to BP110 and a significantly higher preference for Ponto Pro Power among test subjects compared to BP110. Nine of eleven test subjects selected Ponto Pro Power, when asked in the end of the study which device they preferred. The significant difference between devices found in the subjective outcome was not found in the objective outcome measurements.

Stability, Survival, and Tolerability of a 4.5-mm Wide Bone-Anchored Hearing Implant: Six-Month Data from a Randomized Controlled Clinical Trial
Nelissen R C, den Besten C A, Mylanus E A M., Hol M K S, Eur Arch Otorhinolaryngology, March 2015
This publication presents results from a large, high-quality, randomized control study of the Wide Ponto implant from a highly respected clinic (Radboud University Medical Center, Nijmegen, The Netherlands). Results with Wide Ponto (4.5 mm) and earlier version (3.75 mm) implants were compared with respects to quality of life, skin outcome and implant stability. The implants in both groups were loaded at three weeks without affecting the stability or clinical outcomes. The implant survival was 100%, and measurements showed increased stability with the Wide Ponto implant.

Stability Testing of a Wide Bone-Anchored Device After Surgery without Skin Thinning (Full-text PDF)
Hultcrantz, M, BioMed Research International, January 2015
The study accounts for ten cases of BAHS surgery using Wide Ponto implants and a tissue preserving surgical technique. Loading of the implant was done at 3-4 weeks and stability was monitored using ISQ measurements during the one year follow-up period.
The study confirms and reinforces the results from previous studies that Ponto abutments with the OptiFit design in combination with minimal invasive surgical techniques is a safe procedure and gives excellent outcomes.

Minimally Invasive Surgery for Osseointegrated Auditory Implants: A Comparison of Linear versus Punch Techniques
Gordon, Steven A. and Coelho, Daniel H., Otolaryngology February, 2015
The study supports a growing trend toward minimally invasive installation of Ponto implants.
There was no differences in incidence of skin reactions between the minimally invasive punch technique compared to the linear technique with soft tissue reduction and the surgical time was found to be significantly shorter (average 13 min vs 49 minutes). The authors conclude that “the punch technique offers several potential surgical and cosmetic advantages over the linear technique without compromising skin-reactivity outcomes”.

Percutaneous Bone-Anchored Hearing Implant Surgery
Without Soft-Tissue Reduction: Up to 42 Months of Follow-up

Singam, Williams, Saxby & Houlihan, Otology & Neurotology, July 2014
In this study, thirty patients operated using a tissue preservation technique were followed retrospectively. The longest follow-up time was 3.5 years. 22 (73%) of the patients were implanted with Ponto implants and abutments, none of them requiring revision surgery. One abutment change, to a longer 12mm abutment due to skin thickness, was noted in this group. Of the remaining 8 patients with non-Ponto implants, three patients (38%) required revision surgery. The authors conclude that tissue preservation ”… seems to be a safe technique with consistently good results, decreasing operating time and patient morbidity and avoiding some of the complications seen in traditional techniques using soft-tissue reduction.” In addition, they state that “We now predominantly use the new Oticon abutments, the shape of which seems ideally suited for soft-tissue preservation”.

Evaluation Oticon Medical Ponto Plus and Ponto Pro Sound Processor
Bosman, Hol, Snik & Mylanus, Audiology Online, Article 12616, May 2014
In this study potential benefits with Ponto Plus or Ponto Plus & Ponto Streamer over Ponto Pro were evaluated on 19 test subjects. The additional gain for mid and high frequencies in Ponto Plus relative to Ponto Pro showed no effect on speech perception in noise. However, Sound quality with Ponto Plus was rated better than with Ponto Pro. When watching television and talking on the phone Ponto Plus & Streamer was rated better than Ponto Pro alone. Also the overall preference ‘Ponto Plus & Streamer’ showed that 13 out of 19 test subject preferred ‘Ponto Plus & Streamer’ over Ponto Pro.

Initial experience of a rapid-insertion bone-anchored hearing system: series of 20 consecutive implants
Muzaffar, Coulson, Burrell & Reid, J Laryngol Otol., April 2014
Using the Oticon Medical Xpress fitting mechanism and Ponto implant, this study investigated the feasibility of using the sound processor already two weeks after surgery. Twenty implants were included in the study. All patients underwent skin reduction surgery using a split skin graft technique. Approximately half the patients started to use the sound processor after two weeks. Delayed skin healing was the most common reason for loading later than two weeks. No implant loss or other complications were related to the early loading of the implants. The researchers conclude that loading two weeks after surgery is possible, provided adequate skin healing after surgery.

A New Wide-Diameter Bone-Anchored Hearing Implant-Prospective 1-Year Data on Complications, Implant Stability, and Survival
Foghsgaard & Caye-Thomasen, Otology & Neurotology, March 2014
This study reports one year data of a group of 20 wide Ponto implant patients. Focus is on the clinical aspects of the implant, such as implant stability and the occurrence of complications. The results reveal a very stable implant with fast osseointegration properties showing a continuous stability increase during the study period. The survival rate was 100% in the first year, and in 93% of follow-up visits no skin reactions were seen. The authors conclude: “In conclusion, these first published ISQ measurements on the Ponto Wide implant showed high initial stability and good osseointegration the first year after implantation. No decrease in ISQ was observed after implant loading. As expected, soft tissue reactions rarely occurred and were of only minor severity.”

Digital processing technology for bone-anchored hearing aids: randomized comparison of two devices in hearing aid users mixed or conductive hearing loss
Hill-Feltham, Roberts, & Gladdis, The Journal of Laryngology & Otology, February 2014
This paper present the result of a cross-over study comparing the performance and perceived benefit of Ponto Pro and BP100 and older analog BAHD on 14 experienced BAHD users. Both new devices showed significant improvement over the older analog BAHD in speech-in-noise testing. Also the reported benefit with both Ponto Pro and BP100 was significantly better than with the older analog instruments. Ponto Pro was rated significantly better than the BP100 on overall sound quality and experiences of auditory feedback. However the paper conclude that even if the two new devices differs in terms of signal processing no major difference in user benefit or measured improvement in speech intelligibility can be shown between them.

Evaluation of a new Powerful Bone-Anchored Hearing System: A Comparison Study
Bosman, Hol, Snik & Mylanus, Journal of American Academy of Audiology, June 2013
This paper concludes the results of a direct comparison between Ponto Pro Power (digital) and Baha Inteso (analog) carried out on 18 test subjects. No difference between the two instruments when measuring SRT in quiet was shown, however SRT in noise was 2 dB lower for Ponto Pro Power than for BAHA Intenso. Subjective ratings showed better real world performance with Ponto Pro Power than with BAHA Intenso. Also a strong preference (14 out of 18) for Ponto Pro Power could be reported.

A new bone-anchored hearing implant: short-term retrospective data on implant survival and subjective benefit
Nelissen, Mylanus, Kunst, Pennings, Snik & Hol, Eur Arch Otorhinolaryngol, November 2013
In this study, the results from 31 patients implanted with the Ponto implant system at the world-renowned Radboud University in Nijmegen, The Netherlands are reported. All patients were followed for more than a year, with an average follow-up time of 17 months. The implant survival rate was 96.8%, with a single occurrence of spontaneous implant loss. In 95.7% of all observations, no treatment was required. The authors conclude that the Ponto implant is a clinically stable implant with few skin complications.

A minimally invasive technique for the implantation of bone-anchored hearing devices
Wilson & Kim, Otolaryngol Head Neck Surg, Sept. 2013
In this article, the retrospective results of 40 patients is reported. 11 patients underwent surgery with the use of a dermatome (soft tissue reduction) and 29 patients underwent surgery using a minimally invasive technique. The technique used here is a biopsy punch only technique, requiring no linear incision. The results show that there was no difference in the complication rates between the surgical groups and that the less complicated minimally invasive techniques resulted in significantly shorter surgical time.

Percutaneous osseointegrated implant surgery without skin thinning in children: A retrospective case review
Lanis & Hultcrantz, Otology & Neurotology, June 2013
This study of 34 children compares the outcomes after installing implants with or without skin thinning. This is the first paper focusing on the novel tissue preservation technique in pediatric patients. A control group consists of children operated using the classic technique with skin thinning. The authors report that the children operated without skin thinning experienced fewer complications, shorter time in surgery, and improved cosmetic appearance. They conclude that tissue preservation technique that has recently been implemented in adults, is also beneficial for children.

Outcome of the bone-anchored hearing aid procedure without skin thinning: a prospective clinical trial
Hultcrantz, Otology & Neurotology, Sept. 2011
This prospective trial of 14 patients is the first study published on the tissue preservation technique implantation without skin thinning. 7 patients were operated on using the new technique and compared to 7 patients subjected to standard protocol using a dermatome and skin thinning. The study includes the 12mm long abutments from Oticon Medical, a necessity to provide the tissue preservation option to all patients. Prof. Hultcrantz reports shorter surgery time, shorter healing time and fewer complications in the form of numbness and pain around the implant for the tissue preservation technique.

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