Complications of Transcutaneous Protheses - A Systematic Review of Publications Over the Past 10 Years

Abstract Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011-2021). Data Synthesis The MEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1 was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop.

The evaluation of a surgery and the short-term benefits of a new active bone conduction hearing implant - the Osia® / Avaliação da cirurgia e os benefícios a curto prazo de um novo implante auditivo de condução óssea ativa - o sistema Osia®,

Abstract Introduction Modern medicine offers a wide spectrum of different hearing devices, and bone conduction implants can be found among them. Objective The presentation of the outcomes of the implantation of a new active bone conduction hearing implant - the Osia®, and its comparison with the well-known passive transcutaneous system - the Baha® Attract. Methods Eight adult patients with bilateral mixed hearing loss were randomly divided into two groups. Group 1 was implanted with the Osia®, and group 2 was implanted with the Baha® Attract. The details of the surgery were analyzed, along with the functional and audiological results. Results In all the cases, the surgery was successful, and the healing uneventful. In both groups, it was observed that pure tone audiometry and speech audiometry in free field improved significantly after the implantation (mean gain in pure tone audiometry for the Osia group 42.8 dB SPL and for the Baha group 38.8 dB SPL). In the Osia group, the results after the surgery were much better than with the Baha® 5 Power processor on the Softband. The patients implanted with the Osia® evaluated the quality of their hearing as being superior to those implanted with the Baha® Attract. There was an evident improvement in the abbreviated profile of hearing aid benefit questionnaire and in the speech, spatial and qualities of hearing scale for both systems. In the abbreviated profile of hearing aid benefit, changes were more evident in the Osia group (in global score 49% vs. 37.2%). Conclusion Implantation of the Osia® is an effective treatment option for the patients with bilateral mixed hearing loss. The surgery is safe but more complex and time-consuming than the Baha® Attract implantation. The preliminary audiological results as well as the overall quality of life indicate that the Osia® is a better solution than the Baha® Attract. However, future studies should be carried out to make further observations in a larger group of patients, and with longer follow-up.

Resumo Introdução A medicina moderna oferece um amplo espectro de diferentes aparelhos auditivos, e implantes de condução óssea estão entre eles. Objetivo Apresentação dos resultados do uso de um novo implante auditivo de condução óssea ativa - o Osia® e sua comparação com o conhecido sistema transcutâneo passivo - o sistema Baha® Attract. Método Oito pacientes adultos com perda auditiva mista bilateral foram divididos aleatoriamente em dois grupos. O grupo 1 foi implantado com o Osia® e o grupo 2 foi implantado com o sistema Baha® Attract. Os detalhes da cirurgia foram analisados, juntamente com os resultados funcionais e audiológicos. Resultados Em todos os casos, a cirurgia foi bem-sucedida e a cicatrização ocorreu sem intercorrências. Nos dois grupos, observou-se que a audiometria de tons puros e a audiometria de fala em campo livre melhoraram significativamente após o implante (ganho médio na audiometria para tons puros para o grupo Osia® de 42,8 dB NPS e para o grupo Baha®, 38,8 dB NPS). No grupo Osia®, os resultados após a cirurgia foram muito melhores do que com o processador Baha® 5 Power no sistema SoftBand. Os pacientes implantados com o Osia® avaliaram melhor a qualidade de sua audição do que os implantados com o sistema Baha® Attract. Houve uma melhoria evidente no questionário abbreviated profile of hearing aid benefit e na escala speech, spatial and qualities of hearing, para ambos os sistemas. No questionario abbreviated profile of hearing aid benefit, as mudanças foram mais evidentes no grupo Osia® (escore global 49% vs. 37,2%). Conclusão O sistema Osia® é uma opção de tratamento eficaz para pacientes com perda auditiva mista bilateral. A cirurgia é segura, mas mais complexa e demorada que a implantação do sistema Baha® Attract. Os resultados audiológicos preliminares, bem como aqueles avaliando a qualidade de vida, indicam que o Osia® é uma alternativa melhor que o Baha® Attract. Entretanto, mais observações são necessárias em grupos maiores de pacientes e com tempo de seguimento mais longo.

Prevalent Beliefs and Attitude toward Vitiligo among Public in Al Baha Province, Southern Saudi Arabia

ntroduction: Vitiligo is an apparent skin condition that has a psychological impact on the affected individuals and their families. Its prevalence is estimated to be about (0.5-2%) globally. Misunderstandings, and negative attitudes toward vitiligo patients are the most important factors affecting the quality of life of vitiligo patients. Objective:The objective of this study was to identify the common misconceptions and attitudes about the nature, causes and prognosis of vitiligoin Al-Baha region, Saudi Arabia. Methods:A cross sectional study collected data from the general population in the public malls in Al-Baha region, Saudi Arabia. We used a questionnaire which was developed by the authors, the questionnaire included questions regarding vitiligo cause, nature, prognosis and the attitude toward vitiligo Results:A total of (453) responses were analysed, of which (53%) were females, and (90.9%) were Saudis. Theparticipants’ ages ranged from (16 -64) with a mean of (28.3). The majority of our sample had a high level of education; university (65.1%), High school (26%) and less than high school (6%). Our population believed that gecko and its saliva were the commonest cause (38.1%). Most of the respondents (44.4%) thought that the condition is exaggerated by stress and anxiety. Regarding attitude; (31.5%) are unwilling to marry a vitiligo patient. Conclusion:The results of the present study show that the misconceptions and attitudes toward vitiligo are prevalent. Health awareness campaigns should be implanted to educate the people and improve the quality of life of the affected individuals

Identification, characterization and mapping of honey bee flora of Al-Baha region of Saudi Arabia

Aim: The study aimed to identify and document major honey bee flora, their blooming seasons (floral calendar), density and frequency, beekeeping potential areas, and place radius for the major bee flora of the Al-Baha region.Methodology: To identify the honey bee flora of al-Baha region, 420 quadrates were established in different seasons and ecological zones. Plants as honey bee forages were identified through observation of the foraging of honey bees on the flowers for nectar or/and pollen. The density and frequency of each plant was calculated, density and radius maps for major honey bee plants were made using the Arc-Map. Canonical Correspondence Analysis (CCA) was carried out for major honey bee plants using MVSP software. Results: The results showed that more than 550 species of flowering plants were recorded in the study areas, of which 204 plant species belonging to 58 families were identified as honey bee plants. However, only 9 species were found to be an important source of major honeys in the region. The largest number (13%) of honey bee plants was recorded for the family Asteraceae, followed by Lamiaceae, Euphorbiaceae, Fabaceae and Mimosaceae each with 13 (6.4%), 11 (5.4%), 11 (5.4%) and 10 (4.9%) plants, respectively. Each of the remaining families had 1 to 8 species. Interpretation: The radius maps, as well as the blooming periods of honey bee flora will guide beekeepers to move their colonies during the peak flowering periods

Retrospective analysis of skin complications related to bone-anchored hearing aid implant: association with surgical technique, quality of life, and audiological benefit / Análise retrospectiva de complicações cutâneas relacionadas ao implante de prótese auditiva óssea: associação com técnica cirúrgica, qualidade de vida e benefício audiológico

Abstract Introduction: The bone-anchored hearing aid is an effective form of auditory rehabilitation. Due to the nature of the implant, the most common complications are skin related. A number of alternative surgical implantation techniques have been used to reduce the frequency and severity of skin complications, including the U-shaped graft and the linear incision. Objective: To assess skin complications and their association with surgical technique, quality of life, and audiological benefit in patients with bone-anchored hearing aids. Methods: This was a retrospective study conducted in a tertiary referral center in Bogotá, Colombia. Patients who had been fitted with a bone-anchored hearing aid implant (unilaterally or bilaterally) for at least 6 months were included in the study. The Holgers classification was used to classify skin complications (Grade 0 = none; Grade 1 = erythema; Grade 2 = erythema and discharge; Grade 3 = granulation tissue; and Grade 4 = inflammation/infection resulting in the removal of the abutment). The Glasgow Benefit Inventory questionnaire was used to determine quality of life, and the Abbreviated Profile of Hearing Aid Benefit questionnaire was used to determine the subjective audiological benefit. Results: A total of 37 patients were included in the study (30 with unilateral implants and 7 with bilateral implant). Of the 44 implants evaluated, 31 (70.3%) were associated with skin complications (7 [15.9%] Grade 1; 4 [9.1%] Grade 2; 15 [34.1%] Grade 3, 5 [11.4%] Grade 4). The U-shaped graft was statistically associated with major complications (Grades 3 and 4) compared with the linear incision technique (p = 0.045). No statistically significant differences were found between Abbreviated Profile of Hearing Aid Benefit scores and severity of complications. Similarly, no differences were found between Glasgow Benefit Inventory physical health questions and skin complications. Conclusion: Despite the high frequency, skin complications did not seem to affect quality of life or subjective audiological benefits of patients with bone-anchored hearing aids.

Resumo Introdução: A prótese auditiva óssea (BAHA, do inglês Bone-Anchored Hearing Aid) é uma forma eficaz de reabilitação auditiva. Devido à natureza do implante, as complicações mais comuns são relacionadas à pele. Várias técnicas opcionais de implantação cirúrgica têm sido usadas para reduzir a frequência e a gravidade das complicações cutâneas, inclusive o enxerto em forma de U e a incisão linear. Objetivo: Avaliar as complicações cutâneas e sua associação com a técnica cirúrgica, qualidade de vida e benefício audiológico em pacientes com BAHAs. Método: Estudo retrospectivo feito em um centro terciário de referência em Bogotá, Colômbia. Os pacientes que receberam um implante de BAHA (unilateral ou bilateralmente) durante pelo menos seis meses foram incluídos no estudo. A classificação de Holgers foi usada para classificar as complicações cutâneas (Grau 0 = nenhuma, Grau 1 = eritema, Grau 2 = eritema e secreção, Grau 3 = tecido de granulação e Grau 4 = inflamação/infecção, resultou na remoção da estrutura de apoio). O questionário Glasgow Benefit Inventory (GBI) foi usado para determinar a qualidade de vida e o questionário Abbreviated Profile of Hearing Aid Benefit (APHAB) foi usado para determinar o benefício audiológico subjetivo. Resultados: Foram incluídos 37 pacientes (30 com implantes unilaterais e sete com implantes bilaterais). Dos 44 implantes avaliados, 31 (70,3%) foram associados às complicações cutâneas (sete [15,9%] Grau 1; quatro [9,1%] Grau 2; 15 [34,1%] Grau 3 e cinco [11,4%] Grau 4). O enxerto em forma de U foi estatisticamente associado a complicações maiores (Graus 3 e 4) em comparação com a técnica de incisão linear (p = 0,045). Não foram encontradas diferenças estatisticamente significativas entre os escores APHAB e gravidade das complicações. Do mesmo modo, não foram encontradas diferenças entre as questões de saúde física pelo questionário GBI e complicações cutâneas. Conclusão: Apesar da alta frequência, as complicações cutâneas não parecem afetar a qualidade de vida ou os benefícios audiológicos subjetivos de pacientes com BAHAs.

Estudio comparativo en pacientes usuarios de implantes Vibrant Soundbridge® (VSB) y sistema osteointegrado BAHA® / Comparative study on patients users of Vibrant Soundbridge® and osseointegrated BAHA® implants

Objetivo: presentar la experiencia de una institución en la rehabilitación de pacientes con pérdida auditiva utilizando el implante de oído medio Vibrant Soundbridge® (VSB). Diseño: estudio retrospectivo. Materiales y métodos: se revisaron registros médicos, quirúrgicos y audiológicos de pacientes a los que se les implantó el sistema Vibrant Soundbridge (VSB), evaluando la ganancia auditiva establecida por la diferencia en los promedios de las frecuencias 0.5 a 3 kHz en la audiometría tonal postimplante con el sistema y sin él. Se evaluó también la satisfacción de uso con el dispositivo mediante la encuesta Escala de Satisfacción de Audición con Dispositivo (HDSS, Hearing Device Satisfaction Scale). Realizamos comparación de desenlaces audiológicos con una población de usuarios de similares características del sistema osteointegrado BAHA®. Resultados: 25 pacientes con pérdida auditiva predominantemente mixta recibieron un implante VSB colocando el Transductor de Masa Flotante (FMT) en ventana redonda en 23 casos (92%). La ganancia auditiva promedio fue de 36 ± 16 decibeles (dB). No se identificaron diferencias significativas en la ganancia auditiva entre los procesadores AP404-36 dB y Amadé-38 dB, p = 0.6. La ganancia auditiva en el grupo de usuarios del sistema BAHA fue de 37 dB y la discriminación de lenguaje a 65 dB fue de 93% y 100% para VSB y BAHA® respectivamente. En ambos sistemas el puntaje global de satisfacción fue de 4/5.

Objective: Present the institutional experience on the auditory rehabilitation of patients implanted with the middle ear prosthesis Vibrant Soundbridge®. Design: Retrospective study of a cases series. Materials and Methods: Medical, surgical and audiological charts review of patients implanted with the middle ear system VSB. Hearing gain was established by the mean differences calculated on 0.5 to 3 kHz in the pure tone audiometries pre and post implantation, with and without the device. Satisfaction with the device was assessed with the Hearing Device Satisfaction Scale tool. In addition, audiological and satisfaction comparison with a population with similar characteristics of BAHA implant users was made. Results: 25 patients with conductive and mixed hearing loss were implanted with the VSB, placing the FMT on the round window in 23cases (92%). Mean auditory gain was 36 ± 16 decibels (dB). There were no significance gains between processors AP404-36 dB and Amadé-38 dB, p = 0.6. Mean auditory gain in the BAHA® users was 37 dB; speech discrimination at 65 dB was 93% and 100% for VSB and BAHA® users respectively. Overall satisfaction score for both systems was 4/5. Conclusion: The middle ear implant system VSB gives a satisfactory hearing gain to patients with moderate mixed hearing loss comparable with the BAHA® as well in satisfaction and quality of life issues.

Improving the Accuracy of Baha(R) Fittings through Measures of Direct Bone Conduction

OBJECTIVES: Variability in Baha(R) sound processor fittings may arise from the nature of the implant-to-bone transmission as well as transcranial attenuation for patients with single-sided sensorineural deafness (SSD). One method of improving the predictability of Baha fittings is to measure the individual patient's actual bone conduction thresholds, thereby removing the influences of skin thickness and/or the implant location site. METHODS: Twenty adult wearers of the Baha bone conduction implant system participated in the study. Direct bone conduction thresholds were obtained through the BC Direct function of the Baha Fitting Software combined with the Cochlear Baha BP100 sound processor. For comparison, the masked and unmasked bone conduction responses of the patients were collected through standard audiometric testing techniques. Test-retest reliability measurement was performed for all participants. Data for each frequency and frequency range were analyzed separately. RESULTS: The results confirm the improved transmission of sound through the implant rather than transcutaneously through the skin. On average, the BC Direct thresholds were closer to the patient's unmasked thresholds than the masked values. In subjects with SSD, BC Direct results were poorer than contra-lateral bone conduction thresholds, most likely due to transcranial attenuation. The test-retest reliability for the BC Direct measurements was within +/-5 dB. The comparison of preferred amplification, based on direct bone conduction or bone conduction audiometry, found higher agreement for fittings based on direct bone conduction measurements. CONCLUSION: While the transfer function between the implant and the skin can be predicted on average, there are a number of patients for whom measurement is essential to determine the required amplification. These were patients with: 1) SSD, 2) asymmetrical hearing loss, 3) unusual implant location or skull formation, and 4) users of Testband or Softband. The result for the clinician is that a fitting can take place with less fine-tuning and a greater understanding of the variability of bone conducted sound transmission.

Hearing Performance Benefits of a Programmable Power Baha(R) Sound Processor with a Directional Microphone for Patients with a Mixed Hearing Loss

OBJECTIVES: New signal processing technologies have recently become available for Baha(R) sound processors. These technologies have led to an increase in power and to the implementation of directional microphones. For any new technology, it is important to evaluate the degree of benefit under different listening situations. METHODS: Twenty wearers of the Baha osseointegrated hearing system participated in the investigation. The control sound processor was the Baha Intenso and the test sound processor was the Cochlear(TM) Baha(R) BP110power. Performance was evaluated in terms of free-field audibility with narrow band noise stimuli. Speech recognition of monosyllabic phonetically balanced (PB) words in quiet was performed at three intensity settings (50, 65, and 80 dB sound pressure level [SPL]) with materials presented at 0 degrees azimuth. Speech recognition of sentences in noise using the Hearing in Noise Test (HINT) in an adaptive framework was performed with speech from 0 degrees and noise held constant at 65 dB SPL from 180 degrees. Testing was performed in both the omni and directional microphone settings. Loudness growth was assessed in randomly presented 10 dB steps between 30 and 90 dB SPL to narrow band noise stimuli at 500 Hz and 3,000 Hz. RESULTS: The test sound processor had significantly improved high frequency audibility (3,000-8,000 Hz). Speech recognition of PB words in quiet at three different intensity levels (50, 65, and 80 dB SPL) indicated a significant difference in terms of level (P0.05). Speech recognition of sentences in noise demonstrated a 2.5 dB signal-to-noise ratio (SNR) improvement in performance for the test sound processor. The directional microphone provided an additional 2.3 dB SNR improvement in speech recognition (P<0.0001). Loudness growth functions demonstrated similar performance, indicating that both sound processors had sufficient headroom and amplification for the required hearing loss. CONCLUSION: The test sound processor demonstrated significant improvements in the most challenging listening situation (speech recognition in noise). The implementation of a directional microphone demonstrated a further potential improvement in hearing performance. Both the control and test sound processors demonstrated good performance in terms of audibility, word recognition in quiet and loudness growth.

Bionomics of phlebotomine sand flies (Diptera: Psychodidae) in the province of Al-Baha, Saudi Arabia

The bionomics of phlebotomine sand flies (Diptera: Psychodidae) were studied for two successive years (January 1996-December 1997) at 12 collecting stations representing six sectors of the province of Al-Baha, Saudi Arabia. The predominant species was Phlebotomus bergeroti (41.7 percent), followed by lesser numbers of Phlebotomus sergenti (11 percent), Phlebotomus arabicus (10.6 percent), Sergentomyia tiberiadis (10.5 percent), Phlebotomus papatasi (10.2 percent), Sergentomyia antennata (9.6 percent), Phlebotomus alexandri (3 percent), Phlebotomus orientalis (2.3 percent) and Sergentomyia clydei (1.1 percent). The distribution of the collected species including species that are elsewhere known to act as vectors of human cutaneous leishmaniasis were distributed across different altitudes in Al-Baha. P. bergeroti, P. papatasi and P. arabicus were more abundant indoors; however, P. sergenti was more abundant outdoors. Sand fly populations exhibited three patterns of seasonal abundance in terms of their monthly activity. P. bergeroti, P. sergenti and P. arabicus were found to be naturally infected with Leishmania-like flagellates at an infection rate of 0.2 percent.