Clinical publications on the Ponto system

 

Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing

Kruyt IJ., Nelissen RC., Mylanus EAM., Hol MKS. March 2018

Implant stability, survival and tolerability of a 4.5-mm-wide (test) and a 3.75-mm-wide (control) Ponto implant were compared in a prospective randomized controlled clinical trial, including 60 implants in 57 adult patients. Tissue preservation surgery was used and the implants were loaded with the sound processor after three weeks. The mean area-under-the-curve (AUC) of ISQ-low was statistically significantly higher for the test implant (65.7 versus 61.4, p=0.0002). Both implants showed high survival rates (97.4% versus 95.0%, p=0.6374). Adverse soft tissue reactions were observed sporadically, with no significant inter-group differences. Skin thickening was seen in the majority of the patients, but no correlation with adverse soft tissue reactions or implant type was observed. It was concluded that the 4.5-mm-wide implant provides significantly higher ISQ values during the first three years after surgery compared with the previous generation 3.75-mm-wide implant. Both implants showed high survival rates and good tolerability. These long-term results indicate that the wider implant, loaded with a sound processor at three weeks, is a safe and well-performing option for hearing rehabilitation in specific types of hearing loss

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Assessment of discrimination ability in ipsilateral and contralateral ears with a unilateral bone-anchored hearing system.

Celikgun, B., Kalcioglu, T. August 2017.
This study aims to determine the speech discriminatory ability of the contralateral ear of users of a unilateral bone-anchored hearing system (BAHS). Five BAHS users were included in the study. Pure-tone air-conduction thresholds at 250 to 6000 Hz, masked and unmasked bone-conduction thresholds at 250 to 4000 Hz, and speech discrimination scores (monosyllabic and trisyllabic word lists) in both ears were determined. The ipsilateral ear (the BAHS side) was then masked with wide-band noise using an insert earphone, and the word tests were repeated. A mild, but not statistically significant, decrease was observed in monosyllabic words in ipsilateral masking. With trisyllabic words, no decrease was observed in any participants. Based on the results from the five participants in this study, the authors conclude that unilateral BAHS application provided sufficient stimulus to prevent neural deprivation of the contralateral ear. However, they also acknowledge that “Bilateral BAHS is important for localization and discrimination in the context of noise”.

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Direct cost comparison of minimally invasive punch technique versus traditional approaches for percutaneous bone anchored hearing devices.

Sardiwalla Y, Jufas N, Morris DP. June 2017
The study aimed to test the null hypothesis that Minimally Invasive Ponto Surgery (MIPS) and open approaches have the same direct costs for the implantation of percutaneous bone anchored hearing devices in a Canadian public hospital setting. A retrospective simple cost comparison of the two approaches was made considering time, staff and equipment needs. All 12 operations were performed on adult patients from 2013 to 2016 by the same surgeon at a single hospital site. The authors conclude that MIPS technique was more cost effective than traditional open approaches; MIPS had a total mean reduction in cost of CAD$456.83 per operation from the hospital perspective when compared to open approaches.  

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Laser-modified surface enhances osseointegration and biomechanical anchorage of commercially pure titanium implants for bone-anchored hearing systems

Shah FA, Johansson ML, Omar O, Simonsson H, Palmquist A, Thomsen P, June 2016
Osseointegrated implants inserted in the temporal bone are a vital component of bone anchored hearing systems (BAHS). Despite low implant failure levels, early loading protocols and simplified procedures necessitate the application of implants which promote bone formation, bone bonding and biomechanical stability. 

In this study screw-shaped, commercially pure titanium implants were selectively laser ablated within the thread valley and inserted in rabbit tibiae during eight weeks. State-of-the-art machined implants served as controls. Bone-implant contact, bone area in threads, extracellular matrix composition and osteocyte densities were similar for the machined and laser-modified implants. In contrast, laser-modified surfaces demonstrated a 150% higher biomechanical anchorage, a distinctly different load-deformation pattern and a fractured interface in the surrounding bone rather that at the implant-tissue interface during torque. Transmission electron microscopy showed canaliculi in close proximity to the laser-modified surface, in addition to a highly ordered arrangement of collagen fibrils aligned parallel to the implant surface contour.

It is concluded that the physico-chemical surface properties of laser-modified surfaces (thicker oxide, micro- and nanoscale texture) promote bone bonding which may be of benefit in situations where large demands are imposed on biomechanically stable interfaces, such as in early loading and in compromised conditions.

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Implantation of bone-anchored hearing devices through a minimal skin punch incision vs. 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 maintaining good skin tolerance. The percentage of normal-to-moderate skin reactions (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 abutments than with shorter abutments; this may be the main drawback of longer abutments.

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Short-term results from 76 patients receiving a bone anchored hearing implant implanted with a novel minimally invasive surgery technique

Johansson, M., Stokroos, R.J., Banga, R., Hol, M.K., Mylanus, E.A., Savage Jones, H., Tysome, J.R., Vannucchi, P., Hof, J.R., Brunings, J.W., van Tongeren, J., Lutgert, R.W., Banerjee, A., Windfuhr, J.P., Caruso, A., Giannuzzi, A.L., Bordin, S., Hanif, J., Schart-Morén, N., Singam, S., Jonhede, S., Holmberg, M., Cremers, C.W. and Hultcrantz, M. December 2016
The publication evaluates results from a multicentre service evaluation using the Wide Ponto Implant implanted using first-generation Minimally Invasive Ponto Surgery (MIPS) components. Minimally Invasive Ponto Surgery is a refinement of tissue preservation and punch-only surgeries. With the MIPS technique, the drilling procedure is performed through a cannula, and implant implantation is completed through the incision created by a 5-mm biopsy punch. Seventy-seven implants were implanted in 76 adult patients. After a follow-up period of 20–49 weeks, 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 these preliminary results, MIPS instruments have been further improved and further evaluation is in progress.

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Minimally Invasive Ponto Surgery compared to a linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomised controlled trial.

Calon, T.G., van Hoof, M., van den Berge, H., de Bruijn, A.J., van Tongeren, J., Hof, J.R., Brunings, J.W., Jonhede, S., Anteunis, L.J., Janssen, M., Joore, M.A., Holmberg, M., Johansson, M.L. and Stokroos, R.J. November 2016
The publication describes the study protocol of the first trial to compare the recently developed MIPS technique with the linear incision technique with soft tissue preservation for BCHI surgery. The primary investigation centre is Maastricht University Medical Centre. Sixty-two participants will be included in the study, which has a follow-up period of two years. Parameters are introduced in order to quantify factors including 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 predicting the risk of complications. To gain further understanding of peri-abutment dermatitis (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 evaluate the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment surgery parameters, 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 aesthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation.

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Bone-anchored hearing implants without skin thinning: the Gruppo Otologico surgical and audiological experience

Caruso, A., Giannuzzi, A.L., Sozzi, V. & Sanna, M., European Archives of Oto-rhino-laryngology. 2016 September 14 
The study investigates the surgical and audiological outcomes of installation of Ponto implants and abutments without tissue reduction. 
Forty-nine patients aged eighteen or older were included in the study. Data regarding surgical intervention, quality of life (GBI), skin and soft tissue reactions (Holgers classification), 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 all visits. Quality of life (GBI) generally improved in the aided condition compared with prior to implantation. Audiologically speaking, 100% of the 20 patients examined showed improved speech reception and sound field thresholds when comparing aided to unaided. An average improvement of 33 dB on PTA was recorded. 
The study, which presents data from a large population treated with tissue preservation and modern titanium implants, shows that this is a viable solution that has a low risk of complications, high degree of predictability and good audiological results.

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Using speech recall in hearing aid fitting and outcome evaluation under ecological test sonditions.

Lunner T, Rudner M, Rosenbom T, Ågren J, Ng EH. July 2016
In this study a Danish version of Sentence-final Word Identification and Recall test (SWIR), known as the Sentence-final Word Identification and Recall Test in a New Language (SWIRL) is introduced and evaluated in two experiments. The objective of the first experiment was to determine if the results from previous studies in Swedish, demonstrating benefit from noise reduction signal processing for hearing aid wearers, could be replicated in 25 Danish participants with mild to moderate symmetrical sensorineural hearing loss. The objective of the second experiment was to compare direct-drive and skin-drive transmission in 16 Danish users of bone-anchored hearing aids with conductive or mixed  hearing losses. In the first experiment, performance on SWIRL improved when hearing aid noise reduction was used, replicating the Swedish results and generalizing them across languages. In the second experiment, performance on SWIRL was better for direct-drive (abutment) compared with skin-drive (soft band) transmission conditions, showing an increased ability to recall words with the direct-drive (abutment). These findings indicate that spoken word recall can be used to identify benefits from hearing aid signal processing at ecologically valid, positive SNRs where SRTs are insensitive.

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Wireless and acoustic hearing with bone-anchored hearing devices

Bosman, A.J., Mylanus, E.A., Hol, M.K., Snik, A.F., International Journal of Audiology, May 2016
Nineteen subjects compared the Ponto Plus with Streamer to the Ponto Pro. Laboratory testing demonstrated 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.
Subjective 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 a landline or mobile phone and watching TV. Additionally, annoyance caused by ambient noise was strongly reduced when using the Streamer for mobile phone use and watching TV over Ponto Pro.

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Controlled clinical trial on bone-anchored hearing implants and a surgical technique with soft tissue preservation 

den Besten, C.A., Bosman, A.J., Nelissen, R.C., Mylanus, E.A. & Hol, M.K. Otology & Neurotology, March 2016 
The publication examines the results of a prospective cohort study using Wide Ponto Implants, comparing treatment using a linear incision with soft tissue preservation vs. a standard linear incision with soft tissue reduction. Twenty-five patients were enrolled in each group and the follow-up period was six months; both clinical and audiological outcomes were included in the study. Tissue preservation resulted in better results on sensitivity and shorter total surgery time. Soft tissue reactions, assessed using 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 when compared with tissue reduction, tissue preservation leads to a generally favourable clinical outcome, comparable audiology results and a significantly shorter surgery time.

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Clinical outcome of a wide-diameter bone-anchored hearing implant and 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 Wide Ponto Implants to evaluate postoperative complications, skin reactions, implant loss and implant stability. Twenty-four adult patients with normal skin quality participated, with follow-up examinations performed ten days, six weeks, six months and one year after surgery. Primary implant stability was good, and a significant increase in the ISQ (implant stability quotient) occurred over the first ten days. The 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.

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Three-week loading of the 4.5-mm wide titanium implant in bone anchored hearing systems

Wazen, J.J., Babu, S., Daugherty, J. & Metrailer, A. American Journal of Otolaryngology, 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 Wide Ponto (4.5-mm) Implant. Thirty adult patients aged eighteen years or older were evaluated using a prospective multicentre design over a follow-up period of one year. The results show a positive linear trend in implant stability measures over time in all subjects. No implants were lost, and skin reactions were limited to Grade 0 and 1 of the modified Holgers classification 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 expressed satisfaction with the earlier use of their processor, and no additional complications were observed.

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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, N.M., Annals of Otology, Rhinology & Laryngology. 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). The 40 patients were evenly divided amongst the dermatome and punch-only groups. Six patients from the dermatome group and sixteen from the punch-only group were given Ponto implants (Oticon Medical). 
The results showed that with the punch-only technique, the surgical time was shorter (15 vs. 30 minutes) and the post-operative healing process seemed better. Skin tolerance with the punch-only technique was at least as good as that obtained with the dermatome technique (85.7% vs. 86%). There appeared to be a 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.

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Comparison of audiological results and patient satisfaction for two osseointegrated bone conduction devices: results of a prospective study

Busch, S., Giere, T., Lenarz, T. and Maier, H., Otology & Neurology, June 2015
This Hannover Medical Centre study presents results from a prospective crossover study comparing audiological objective and subjective outcomes between the Ponto Pro Power (Oticon Medical) and BP110 (Cochlear). Eleven test subjects with conductive or mixed hearing loss participated in the study. 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 among test subjects for Ponto Pro Power over the BP110. Nine of eleven test subjects selected the Ponto Pro Power when asked which device they preferred at the end of the study. The significant difference between devices found in the subjective outcomes was not replicated in the objective outcome measurements.

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Stability, survival and tolerability of a 4.5-mm wide bone-anchored hearing implant: six-month data from a randomised controlled clinical trial

Nelissen, R.C., den Besten, C.A., Mylanus, E.A;M. & Hol, M.K.S., European Archives of Oto-rhino-laryngology, March 2015
This publication presents results from a large, high-quality, randomised control study of the Wide Ponto implant from a highly respected clinic (Radboud University Medical Centre, Nijmegen, The Netherlands). Results with Wide Ponto (4.5-mm) and earlier version (3.75-mm) implants were compared with regard to quality of life, skin outcome and implant stability. The implants in both groups were loaded at three weeks without affecting stability or clinical outcomes. The implant survival rate was 100%, and measurements showed increased stability with the Wide Ponto implant.

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Minimally invasive surgery for osseointegrated auditory implants: A comparison of linear and punch techniques

Gordon, S.A. and Coelho, D.H., Otolaryngology, February 2015
The study supports a growing trend toward minimally invasive implantation of Ponto implants. 
There was no difference in incidence of skin reactions between the minimally invasive punch technique and linear technique with soft tissue reduction, and the surgery time was found to be significantly shorter (an average of 13 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.”

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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 examines ten cases of BAHS surgery using Wide Ponto implants and a tissue-preserving surgical technique. Implant loading was done at 3–4 weeks, and stability was monitored using ISQ measurements taken over the one-year follow-up period. 
The study confirms and reinforces the results of previous studies showing that Ponto abutments with the OptiFit™ design, in combination with minimal invasive surgical techniques, are a safe procedure and provide excellent outcomes.

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Percutaneous bone anchored hearing implant surgery without soft tissue reduction: up to 42 months of follow-up

Singam, Williams, Saxby and Houlihan, Otology & Neurotology, July 2014
This retrospective study followed thirty patients who had undergone surgery using a tissue preservation technique. 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 12-mm abutment due to skin thickness, was observed in this group. Of the remaining eight 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.”

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Evaluation of Oticon Medical Ponto Plus and Ponto Pro sound processor

Bosman, Hol, Snik & Mylanus, Audiology Online, Article 12616, May 2014
This study of 19 test subjects evaluated the potential benefits of Ponto Plus or Ponto Plus & Ponto Streamer over Ponto Pro. 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 were rated better than Ponto Pro alone. Also, overall preference showed that 13 out of 19 test subjects preferred ‘Ponto Plus & Streamer’ over Ponto Pro.

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Initial experience of a rapid-insertion bone-anchored hearing system: series of 20 consecutive implants

Muzaffar, Coulson, Burrell & Reid, Journal of Laryngology & Otology, April 2014
Using the Oticon Medical Xpress fitting mechanism and Ponto implant, this study investigated the feasibility of using the sound processor as soon as 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 of the patients began using the sound processor after two weeks. Delayed skin healing was the most common reason for loading after more than two weeks. No implant loss or other complications were correlated with early loading of the implants. The researchers concluded that loading two weeks after surgery is possible provided that there is adequate skin healing after surgery.

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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 from a group of 20 Wide Ponto Implant patients. The 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 observed. The authors conclude: “In conclusion, these first published ISQ measurements on the Wide Ponto 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.”

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Digital processing technology for bone anchored hearing aids: randomised comparison of two devices in hearing aid users with mixed or conductive hearing loss

Hill-Feltham, Roberts & Gladdis, The Journal of Laryngology & Otology, February 2014
This paper presents the result of a crossover study comparing the performance and perceived benefit of Ponto Pro and BP100 and older analogue BAHD on 14 experienced BAHD users. Both new devices showed significant improvement over the older analogue BAHD in speech-in-noise testing. Additionally, the reported benefits with both Ponto Pro and BP100 were significantly better than with the older analogue instruments. Ponto Pro was rated significantly better than the BP100 on overall sound quality and amount of auditory feedback. However, the paper concludes that even if the two new devices differ in terms of signal processing, no major differences in user benefit or measured improvement in speech intelligibility are observed between them.

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Evaluation of a powerful new bone-anchored hearing system: a comparison study

Bosman, Hol, Snik and Mylanus, Journal of American Academy of Audiology, June 2013
This paper presents the results of a direct comparison between Ponto Pro Power (digital) and Baha Intenso (analogue) carried out on 18 test subjects. No significant difference was found between the two instruments when measuring SRT in quiet; however, SRT in noise was 2 dB lower for the Ponto Pro Power than the Baha Intenso. Subjective ratings showed better real-world performance with the Ponto Pro Power than the Baha Intenso. A strong preference for the Ponto Pro Power (14 out of 18) was also observed.

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A new bone anchored hearing implant: short-term retrospective data on implant survival and subjective benefit

Nelissen, Mylanus, Kunst, Pennings, Snik & Hol, European Archives of Otorhinolaryngology, November 2013
This study reports results from 31 patients implanted with the Ponto implant system at the world-renowned Radboud University in Nijmegen in the Netherlands. All patients were followed for more than a year, with an average follow-up period of 17 months. The implant survival rate was 96.8%, with only one occurrence of spontaneous implant loss. In 95.7% of all cases, no follow-up treatment was required. The authors conclude that the Ponto implant is a clinically stable implant that is very unlikely to cause skin complications.

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A minimally invasive technique for the implantation of bone-anchored hearing devices

Wilson & Kim, Otolaryngology—Head & Neck Surgery, Sept. 2013
This article provides an overview of the retrospective results of 40 patients. Eleven patients underwent surgery using a dermatome (soft tissue reduction), and twenty-nine patients underwent surgery with 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 complication rates between the surgical groups, and the less complicated, minimally invasive techniques resulted in significantly shorter procedure times.

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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 paediatric patients. A control group consists of children operated on using the classic technique with skin thinning. The authors report that the children operated on without skin thinning experienced fewer complications, shorter time in surgery and improved cosmetic appearance. They conclude that the tissue preservation technique that has recently been implemented in adults is also beneficial for children.

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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 tissue preservation technique implantation without skin thinning. Seven 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 12-mm long abutments from Oticon Medical, necessary for providing a tissue preservation option for all patients. Professor Hultcrantz reports that the tissue preservation technique has a shorter surgery time, shorter healing time and fewer complications in the form of numbness and pain around the implant.

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