Post-implantation clinical cost analysis between transcutaneous and percutaneous bone conduction devices.

INTRODUCTION: Bone conduction devices (BCD) are effective for hearing rehabilitation in patients with conductive and mixed hearing loss or single-sided deafness. Transcutaneous bone conduction devices (tBCD) seem to lead to fewer soft tissue complications than percutaneous BCDs (pBCD) but have other drawbacks such as MRI incompatibility and higher costs. Previous cost analyses have shown a cost advantage of tBCDs. The purpose of this study is to compare long-term post-implantations costs between percutaneous and transcutaneous BCDs. MATERIALS AND METHODS: Retrospective data from 77 patients implanted in a tertiary referral centre with a pBCD (n = 34), tBCD (n = 43; passive (tpasBCD; n = 34) and active (tactBCD; n = 9) and a reference group who underwent cochlear implantation (CI; n = 34), were included in a clinical cost analysis. Post-implantation costs were determined as the sum of consultation (medical and audiological) and additional (all post-operative care) costs. Median (cumulative) costs per device incurred for the different cohorts were compared at 1, 3 and 5 years after implantation. RESULTS: After 5 years, the total post-implantation costs of the pBCD vs tpasBCD were not significantly different (€1550.7 [IQR 1174.6-2797.4] vs €2266.9 [IQR 1314.1-3535.3], p = 0.185), nor was there a significant difference between pBCD vs tactBCD (€1550.7 [1174.6-2797.4] vs €1428.8 [1277.3-1760.4], p = 0.550). Additional post-implantation costs were significantly highest in the tpasBCD cohort at all moments of follow-up. CONCLUSION: Total costs related to post-operative rehabilitation and treatments are comparable between percutaneous and transcutaneous BCDs up to 5 years after implantation. Complications related to passive transcutaneous bone conduction devices appeared significantly more expensive after implantation due to more frequent explantations.

Evaluation of a super powerful bone-anchored hearing system and its users: A retrospective study.

INTRODUCTION: Although the Baha 5SP has been commercially available for six years, very few studies have been performed on the device's efficacy. The current study aims to evaluate the characteristics and audiological results in patients with severe-to-profound mixed hearing loss fitted with this superpower sound processor. METHODS: This retrospective evaluation was conducted at a tertiary referral centre where a series of 82 adult patients with severe-to-profound mixed hearing loss were implanted with a percutaneous bone-anchored hearing system and fitted with a superpower sound processor between 2016 and 2019. Patients with incomplete or unreliable audiological data (n = 24) were excluded, resulting in 58 data sets for analysis. The main outcome measures were unaided and aided pure-tone thresholds and aided free-field speech perception in quiet. RESULTS: The median unaided air conduction (AC) threshold averaged across 0.5, 1 and 2 kHz (PTA0.5-2kHz) of all patients was 75 dB hearing loss (HL); the median unaided AC averaged across 1, 2 and 4 kHz (PTA1-4kHz) was 84 dB HL. For bone conduction and direct bone conduction, the median PTA0.5-2kHz was 52 and 47 dB HL, respectively. With the superpower device, the median free-field speech reception threshold was 54 dB sound pressure level (SPL), and the median speech perception score at 65 dB SPL was 80%. CONCLUSIONS: At least 75% of the patients reached a maximum phoneme score of 70%. For patients with lower scores, the superpower device still provides a substantial hearing benefit. This makes the superpower device particularly suitable for patients with severe-to-profound mixed hearing loss with a contraindication for conventional hearing aids and/or cochlear implants.

Healthcare consumption among subjects with otitis media undergoing middle ear surgery-analysis of cost drivers.

PURPOSE: To map healthcare utilized by subjects with chronic otitis media, with or without cholesteatoma and perform a cost analysis to determine key drivers of healthcare expenditure. METHODS: A registry study of 656 adult subjects with chronic otitis media that underwent a middle ear surgery between 2014 and 2018. Healthcare contacts related to all publicly funded specialist ENT care, audiological care and primary care for a disease of the ear and mastoid process were extracted. The data are extracted from the Swedish National Patient Registry on subjects that reside in western Sweden. RESULTS: Subjects made 13,782 healthcare contacts at a total cost 61.1 million SEK (6.0 million EUR) between 2014 and 2018. The mean cost per subject was 93,075 SEK (9071 EUR) and ranged between 3971 SEK (387 EUR) and 468,711 SEK (45,683 EUR) per individual. In the most expensive quartile of subjects, mean cost was 192,353 SEK (18,747 EUR) over the 5-year period. These subjects made 3227 ENT contacts (roughly four each year) and 60% of total costs were associated with in-patient ENT care. CONCLUSION: Patients with chronic otitis media are associated with high ENT resource utilization that does not diminish after surgical intervention and the disease places a long-term burden on healthcare systems. Significant costs are attributed to revision surgeries, indicating that these patients could be managed more effectively. In many such cases, reoperation cannot be avoided, especially due to recurrence of cholesteatoma. However, in some patients, when the indication for subsequent surgery is only hearing improvement, alternative options, such as hearing aids or implants, should also be considered. This is especially true in difficult cases, where revision ossiculoplasty is likely.

The Merits of Bilateral Application of Bone-Conduction Devices in Children With Bilateral Conductive Hearing Loss.

OBJECTIVES: This study aims to characterize lateralization of sounds and localization of sounds in children with bilateral conductive hearing loss (BCHL) when listening with either one or two percutaneous bone conduction devices (BCDs). DESIGN: Sound lateralization was measured with the minimum audible angle test in which children were asked to indicate from which of the two visible speakers the sound originated. Sound localization was measured with a test in which stimuli were presented from speakers that were not visible to the children. In the sound localization test, 150 ms broadband noise bursts were presented, and sound level was roved over a 20-dB range. Because speakers were not visible the localization response was not affected by any visual cue. The sound localization test provides a clear distinction between lateralization and localization of sounds. Ten children with congenital BCHL and one child with acquired BCHL participated. RESULTS: Both lateralization and sound localization were better with bilateral BCDs compared with the unilaterally aided conditions. In the bilateral BCD condition, lateralization was close to normal in nearly all the children. The localization test demonstrated lateralization rather than sound localization behavior when listening with bilateral BCDs. Furthermore, in the unilateral aided condition, stimuli presented at different sound levels were mainly perceived at the same location. CONCLUSIONS: This study demonstrates that, in contrast to listening with two BCDs, children demonstrated difficulties in lateralization of sounds and in sound localization when listening with just one BCD (i.e., one BCD turned off). Because both lateralization and sound localization behavior were tested, it could be demonstrated that these children are more able to lateralize than localize sounds when listening with bilateral BCDs. The present study provides insight in (sub-optimal) sound localization capabilities of children with congenital BCHL in the unilateral-aided and bilateral-aided condition. Despite the sub-optimal results on sound localization, this study underlines the merits of bilateral application of BCDs in such children.

Auricular prostheses attached to osseointegrated implants: multidisciplinary work-up and clinical evaluation.

PURPOSE: Not long after the introduction of osseointegrated implants outside the oral cavity, auricular prostheses are retrained on osseointegrated implants. New insights have been gained with the next-generation percutaneous osseointegrated titanium implants for bone conduction hearing since its introduction in 2010. As a result, the same technology was introduced in the Vistafix® system (VXI implant) to retain auricular prostheses. The aim of this study is to evaluate the surgical procedure, clinical outcome, and satisfaction of the patient of osseointegration-retained auricular prosthesis using VXI implants. MATERIALS AND METHODS: 11 patients who received an auricular prosthesis using VXI implants between December 2012 and November 2017 were evaluated retrospectively. The patient's medical files were reviewed to assess clinical complications and the necessity for revision surgery. The subjective outcome was measured using the Glasgow benefit inventory (GBI). RESULTS: In total, 31 implants were placed in 11 patients. None of these implants were lost nor revision surgery needed. An adverse skin reaction was observed in 13.0% of the implants and in 27.2% of the patients, adequately treated with an antibiotic ointment. The average follow-up time was 2 years and 7 months. The GBI displayed a positive score in every patient. CONCLUSIONS: The VXI implants used are a safe and reliable treatment option for retaining auricular prostheses in patients with an absent auricle. Patients were satisfied with their auricular prosthesis and showed benefit in quality of life. Studies with larger numbers and preferably a prospective character are needed to draw statistically significant conclusions.

Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study.

OBJECTIVES: To compare the hearing performance of patients with conductive and mild mixed hearing loss and single-sided sensorineural deafness provided with a new transcutaneous bone conduction hearing implant (the Baha Attract System) with unaided hearing as well as aided with a sound processor on a softband. Furthermore, to evaluate safety and subjective benefit before and after implantation of the test device. PARTICIPANTS: Fifty-four adult patients in five participating centres were enrolled in this prospective study. Baseline data were collected during a pre-operative visit, and after a softband trial, all patients were implanted unilaterally. Follow-up visits were scheduled at 10 days, 4, 6, 12 weeks and 6 months. MAIN OUTCOME MEASURES: Free-field hearing thresholds pure-tone average (PTA4 in dB HL; mean threshold at 500, 1000, 2000, 4000 Hz; primary outcome measure). Individual free-field hearing thresholds, speech recognition in quiet and in noise, soft tissue status during follow-up and subjective benefit as measured with the Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech, Spatial and Qualities of Hearing Scale (SSQ) and Health Utilities Index (HUI) questionnaires. RESULTS: Implantation of the Baha Attract System resulted in favourable audiological outcomes compared to unaided conditions. On the primary outcome parameter, a statistically significant improvement was observed compared to unaided hearing for the patients with conductive/mixed hearing loss (mean PTA4 difference -20.8 dB HL, SD 9.8; P < 0.0001) and for the patients with single-sided sensorineural deafness (SSD) (mean PTA4 difference -21.6 dB HL, SD 12.2; P < 0.0001). During all audiology tests, the non-test ear was blocked. Statistically significant improvements were also recorded in speech tests in quiet and noise compared to unaided hearing for the conductive/mixed hearing loss group and for speech in quiet in the SSD group. Compared to the pre-operative measurement with softband, no significant differences were recorded in the PTA4 free-field hearing threshold or the other audiological outcomes in either of the groups (P > 0.05). Soft tissue-related issues observed during follow-up included numbness, pain/discomfort at the implant site and to a lesser extent pressure-related skin complications. A declining trend was noted in the rate of these complications during follow-up. Approximately 20% of patients reported some degree of numbness and 38% (slight) pain/discomfort at final follow-up of 6 months. Good results on the subjective benefit questionnaires were observed, with statistically significant improvements on APHAB and SSQ questionnaires, and on the hearing attribute of HUI3. CONCLUSIONS: The Baha Attract System provided a significant improvement in hearing performance and subjective benefit compared to the pre-operative unaided condition (with the non-test ear blocked). Hearing performance of the Baha Attract was similar to a test situation with the same sound processor on a softband. A proportion of the patients reported numbness and pain/discomfort at the implant site during follow-up, especially during the first post-operative weeks. Based on the results of the current multicentre study, the Baha Attract can be considered as a treatment option for patients with the aforementioned hearing losses. Especially in the SSD patients, a careful selection procedure is warranted. Therefore, a pre-operative trial should be part of the decision-making process before fitting a patient with the Baha Attract System.

Percutaneous bone-anchored hearing implant surgery: dermatome versus linear incision technique.

The objective of this historical cohort study is to identify if there are differences in soft tissue reactions and skin thickening between implantation of the percutaneous bone-anchored hearing implant (BAHI) using the dermatome or linear incision technique. All adult patients who received a BAHI between August 2005 and January 2013 were selected. One surgeon performed all procedures and only the dermatome and linear incision technique were used. A total of 132 patients/implants were included and significantly more patients with risk factors were seen in the linear incision cohort. A soft tissue reaction Holgers ≥1 was present in 18 patients (40.9 %) in the dermatome compared to 36 patients (40.9 %) in the linear incision group. A Holgers ≥2 was noticed in 9 (20.5 %) and 19 (21.6 %) patients, respectively. Skin thickening was described in 14 (31.8 %) and 11 patients (12.5 %) in, respectively, the dermatome and linear incision cohort, which was a significant difference (p = 0.001). Nevertheless, therapeutic interventions were effective. In conclusion, there was no significant difference in (adverse) soft tissue reactions; however, skin thickening was more present in the dermatome technique. In addition, significantly more patients with risk factors were allocated to the linear incision technique. Based on these results, the linear incision is advocated as preferred technique.

Three-year experience with the Sophono in children with congenital conductive unilateral hearing loss: tolerability, audiometry, and sound localization compared to a bone-anchored hearing aid.

Bone conduction devices (BCDs) are advocated as an amplification option for patients with congenital conductive unilateral hearing loss (UHL), while other treatment options could also be considered. The current study compared a transcutaneous BCD (Sophono) with a percutaneous BCD (bone-anchored hearing aid, BAHA) in 12 children with congenital conductive UHL. Tolerability, audiometry, and sound localization abilities with both types of BCD were studied retrospectively. The mean follow-up was 3.6 years for the Sophono users (n = 6) and 4.7 years for the BAHA users (n = 6). In each group, two patients had stopped using their BCD. Tolerability was favorable for the Sophono. Aided thresholds with the Sophono were unsatisfactory, as they did not reach under a mean pure tone average of 30 dB HL. Sound localization generally improved with both the Sophono and the BAHA, although localization abilities did not reach the level of normal hearing children. These findings, together with previously reported outcomes, are important to take into account when counseling patients and their caretakers. The selection of a suitable amplification option should always be made deliberately and on individual basis for each patient in this diverse group of children with congenital conductive UHL.

Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial.

The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test-control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.

Percutaneous bone-anchored hearing implant surgery: inside or outside the line of incision?

The objective of this historical cohort study was to compare soft tissue reactions in adults after bone-anchored hearing implant (BAHI) surgery when the percutaneous implant is placed inside or outside the line of incision. All adult patients who received a percutaneous BAHI between 1 January 2010 and 31 January 2014 in our tertiary referral centre were identified. Patients were selected if operated by two surgeons, who perform the same standardised linear incision technique with one of them placing the implant outside the incision while the other prefers placement inside the line of incision. A total of 202 patients and 211 implants were included in the case analysis. The results showed the registration of a soft tissue reaction Holgers ≥1 in 47 implants (49.0 %) placed outside the incision compared to 70 implants (60.9 %) which were placed inside the line of incision. An adverse soft tissue reaction, Holgers ≥2, was noticed in 17 implants (17.7 %), respectively, 20 implants (17.4 %). No significant differences were found between the two groups for both the presence of soft tissue reactions Holgers ≥1 (p = 0.322) and a Holgers score ≥2 (p = 0.951). During the follow-up three implants were lost (1.4 %) and in 18 of 211 implants one or multiple revisions were performed (8.5 %). In conclusion, this study did not show any differences in the presence of postsurgical (adverse) soft tissue reactions between placement of the percutaneous BAHI inside or outside the line of incision.

Loading of osseointegrated implants for bone conduction hearing at 3 weeks: 3-year stability, survival, and tolerability.

The objective of this study was to ascertain the long-term safety of loading osseointegrated implants for bone conduction hearing 3 weeks post-surgery. Thirty consecutive adult patients were implanted with the Baha BI300 (Cochlear Bone Anchored Solutions) in our tertiary referral center. Implants were loaded with the sound processor 3 weeks post-surgery. Follow-up examinations were performed at 10 days; 3, 4, 6, 8, and 12 weeks; 6 months; and 1, 2, and 3 years after implant surgery. At each follow-up visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis, and soft tissue status was evaluated according to Holgers' classification. ISQ trends, implant survival, and soft tissue reactions were compared to a population of 52 patients with the same type of implants loaded from 6 weeks post-surgery as part of another study. Subjective benefit was measured by means of the Glasgow Benefit Inventory (GBI). After an initial dip in ISQ at 10 days after implantation, a gradually increasing trend in ISQ was found until 6 months in both populations, after which ISQ values remained above baseline values. Implant survival was 97 % in the study population and 96 % in the comparison population. Clinically relevant soft tissue reactions were found in 0.9 % (study population) and 1.7 % (comparison population) of all visits. Patients reported subjective benefit; the mean GBI score was 22.8. In conclusion, loading these implants at 3 weeks post-surgery is safe based on the current study, as long-term results show high ISQ values and good implant survival and tolerability.

Wireless and acoustic hearing with bone-anchored hearing devices.

OBJECTIVE: The efficacy of wireless connectivity in bone-anchored hearing was studied by comparing the wireless and acoustic performance of the Ponto Plus sound processor from Oticon Medical relative to the acoustic performance of its predecessor, the Ponto Pro. STUDY SAMPLE: Nineteen subjects with more than two years' experience with a bone-anchored hearing device were included. Thirteen subjects were fitted unilaterally and six bilaterally. DESIGN: Subjects served as their own control. First, subjects were tested with the Ponto Pro processor. After a four-week acclimatization period performance the Ponto Plus processor was measured. In the laboratory wireless and acoustic input levels were made equal. In daily life equal settings of wireless and acoustic input were used when watching TV, however when using the telephone the acoustic input was reduced by 9 dB relative to the wireless input. RESULTS: Speech scores for microphone with Ponto Pro and for both input modes of the Ponto Plus processor were essentially equal when equal input levels of wireless and microphone inputs were used. Only the TV-condition showed a statistically significant (p <5%) lower speech reception threshold for wireless relative to microphone input. In real life, evaluation of speech quality, speech intelligibility in quiet and noise, and annoyance by ambient noise, when using landline phone, mobile telephone, and watching TV showed a clear preference (p <1%) for the Ponto Plus system with streamer over the microphone input. Due to the small number of respondents with landline phone (N = 7) the result for noise annoyance was only significant at the 5% level. CONCLUSION: 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. The preference of wirelessly transmitted audio when watching TV can be attributed to the relatively poor sound quality of backward facing loudspeakers in flat screen TVs. The ratio of wireless and acoustic input can be easily set to the user's preference with the streamer's volume control.

Long-Term Outcomes of a Percutaneous Wide-Diameter Bone-Anchored Hearing Implant: A Clinical Evaluation of More than 800 Implants.

OBJECTIVE: This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. STUDY DESIGN: Retrospective cohort study. Mean follow-up period of 3.8 years. SETTING: Tertiary referral center. PATIENTS: All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. MAIN OUTCOME MEASURES: Soft tissue reaction, implant survival, revision surgery, and BCD usage. RESULTS: In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. CONCLUSION: Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.

Long-Term Results of the Linear Incision Technique With Tissue Reduction Versus Tissue Preservation for Inserting Bone-Anchored Hearing Implants: The Ongoing Optimization in Bone Implant Surgery.

OBJECTIVE: To compare the long-term outcomes of the linear incision technique with tissue reduction (LIT-TR) and the linear incision technique with tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs). STUDY DESIGN: Single-center retrospective cohort study. SETTING: Large general teaching hospital. PATIENTS: A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. INTERVENTION: The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). MAIN OUTCOME MEASURES: Soft tissue reactions, skin thickening, postoperative complications (e.g., wound dehiscence), and implant loss were compared between the test and control group. Furthermore, Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden) and Oticon Medical AB (Askim, Sweden) implants/abutments within the LIT-TP cohort were compared. Validated questionnaires were used to quantify patients' health-related quality of life (HRQoL). RESULTS: Significantly more cases with wound dehiscence and adverse soft tissue reactions (Holgers ≥2) were observed in the LIT-TR cohort (p < 0.001). However, the LIT-TP cohort showed significantly more cases with skin thickening (requiring treatment) within the first 2 years after implantation. There were no differences in implant loss rates, overall soft tissue reactions (Holgers >1), and overall HRQoL between the two patient groups. Significant improvement in the patients' HRQoL after implementation of a BAHI was found in both techniques. The Ponto Wide implant/abutment showed less frequent skin thickening (requiring treatment) and fewer soft tissue reactions compared with the BIA400 implant/abutment. CONCLUSION: This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

Bilateral bone conduction devices: improved hearing ability in children with bilateral conductive hearing loss.

OBJECTIVES: The aim of the study was to investigate whether children with bilateral conductive hearing loss benefit from their second device (i.e., the bilateral bone conduction device [BCD]). DESIGN: Speech recognition in noise was assessed in 10 children fitted with bilateral BCDs during childhood. Speech recognition was measured in 2 conditions with both BCDs active. Spatial resolution was tested with the Minimum Audible Angle test in the bilateral and monaural listening conditions. RESULTS: Children demonstrated an improvement in speech recognition when speech was presented from the front and noise was presented from the right-hand side as compared with both speech and noise being presented from the front. The minimum audible angle decreased from 57° in the best monaural condition to 13° in the bilateral condition. CONCLUSIONS: The audiological outcomes demonstrate the advantage of bilateral BCD fitting in children with bilateral conductive hearing loss.

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

This report provides the first short-term follow-up data on the Ponto bone-anchored hearing implant from our tertiary referral centre. Thirty-one consecutive patients with a mean age of 51 years who received the implant between October 2010 and December 2011 were included retrospectively in this study. Implant loss, skin reactions around the implant (according to Holgers' grading system), revision surgery, and abutment replacements were retrospectively gathered from the patients' files as objective outcome measures. To obtain information on subjective patient satisfaction, the Glasgow Benefit Inventory (GBI) was used. The mean follow-up period was 16.9 months (range 12.1-25.2 months). One implant was lost. Over a total of 94 follow-up visits, 21 skin reactions were observed in 16 patients: Holgers grade 1 (slight redness, no need for treatment) in 18.1 % of the visits,and grade 2 (redness and moist, needing conservative treatment) in 4.3 % of the visits. Four 6-mm abutments (12.9 %) were replaced for a 9-mm abutment during the follow-up period, of which one (3.2 %) was in combination with revision surgery. In one patient keloid formation around the implant was observed. The GBI revealed a moderate subjective benefit. The short-term results with these percutaneous implants demonstrate a clinically stable implant with a low percentage of skin reactions that require treatment. Long-term, prospective follow-up data are needed to draw firmer conclusions.