Patients’ Experiences of an Active Transcutaneous Implant: The Bone Conduction Implant

According to the World Health Organization (WHO), hearing loss is sometimes described as the “invisible disease” because it is not possible to tell whether a person has a hearing loss or not [1]. Having a hearing loss can lead to difficulties in communicating with others, affecting not only family life but also social interactions in various contexts. Research on hearing impairment has shown that hearing loss can be linked to adverse consequences, including social isolation, dementia, and a lower level of education [2‒5]. This research highlights the importance of hearing rehabilitation and hearing aids. Hearing rehabilitation usually starts with a tone and speech audiometry to determine degree and type of hearing loss, followed by hearing aid fitting. To evaluate and verify hearing aid fitting, questionnaires, tone and speech sound field measurements and real ear measurements (REMs) can be performed. REM verifies that correct amplification is being prescribed in an air-conduction hearing aid. A similar clinical measurement to REM for bone conducted hearing devices (BCDs) is missing, and it is therefore not possible to verify whether a patient has received the correct amplification in their BCD or not. Ongoing research [6] describes a new method to verify how BCDs stimulate the cochlea in individual patients allowing for a more accurate hearing aid fitting.

A BCD is offered to individuals with a conductive or mixed hearing loss who cannot use an air-conducted hearing aid due to temporary or chronic defects/diseases in the outer ear, ear canal, or middle ear. Another indication is single sided deafness. Bone conduction hearing solutions are divided into two groups: percutaneous and transcutaneous. The percutaneous solution consists of a titanium implant with an abutment through the skin. The hearing device is then attached to the abutment and the sound vibrations are conducted from the hearing device via the skull bone directly to the cochlea without passing through skin and soft tissue. The transcutaneous solution, over intact skin, is either active or passive. Active transcutaneous means that radio signals pass through intact skin, from a hearing device, also called an audio processor, to the implanted speaker which is in direct contact with the skull bone. Thus, sound vibrations do not pass through skin and soft tissue. Passive transcutaneous means that the vibrations pass through the skin and soft tissue to the skull bone or to an implanted magnet under intact skin.

In 2012, a research group in Sweden introduced a new active transcutaneous bone conduction implant (BCI) [7] (Fig. 1). A total of 16 patients have received the BCI, and several studies have been published examining the surgical method and the patient’s performance in various audiological speech tests as well as questionnaires [8‒11]. However, none of these studies have explored the patients experience of living with and using a BCI, through a qualitative study approach.

To the best of our knowledge, only two qualitative studies have been published about patients using BCDs. In a qualitative study by Almugathwi et al. [12], the authors have analyzed text messages posted on an online support group for patients who are candidates for, or are using a percutaneous BCD. The purpose was to gain insight into the decision-making process. The study presented how patients sought information online and how it helped them make decisions regarding surgery. The authors acknowledged limitations, such as the reliance on a single online support group and the possibility that not all users would contribute to the online discussion.

The study suggested that conducting interviews could provide a broader perspective, especially concerning patients who reject a bone conductive hearing solution. In another similar study by McFarland et al. [13], telephone interviews were conducted to investigate the reasons why patients either accept or decline a bone conduction hearing solution. The authors found that it is important to explore the patient’s individual concerns and priorities because deciding to accept or reject a bone conductive hearing solution was highly individual. One limitation that the authors discuss is that all patients come from a one-audiology clinic and that the result might have been different if more clinics had been included. In the current study, the aim was to explore and describe patients’ experiences of using and living with the BCI.

The study was performed utilizing a qualitative research methodology based on interviews. The interviews were analyzed according to the phenomenographic approach which is particularly suitable for capturing a wide range of experiences related to a specific phenomenon [14]. In this study, the phenomenon under investigation was experiences of using and living with the BCI.

For this qualitative study, individual interviews were chosen as the method for data collection. Participants were invited by post and asked to return a reply letter and state whether they were interested to take part in the study or not, and those who were interested were contacted and a mutually convenient date and location for the interview were scheduled. Most of the interviews took place in a room at a university, and some at a hearing clinic. All interviews started with verbal information about the aim of the study, followed by questions about the participants’ background with the BCI (Table 1). The duration of the interviews was between 22 and 60 min and was all audio-recorded. The main open interview question was “Can you describe your experiences of using and living with BCI?” Follow-up questions were then based on the participants’ responses, allowing for a more in-depth exploration of their experiences. The interviews could therefore evolve somewhat differently depending on what the participants chose to describe. All interviews and transcriptions were conducted by one of the authors (A.P.).

In this study, a total of 10 patients were interviewed. Out of the 16 patients who had received the BCI, two nonusers were excluded from the study. Fourteen patients were initially invited, two of them could not participate due to unrelated health conditions, and two declined for unspecified reasons. The participants consisted of four males and six females, with an average age of 50 years (range 28–76 years). All participants live in the southern part of Sweden and have a varying level of experience with BCI, ranging from 6 to 10 years. Additionally, two of the participants used an air-conducted hearing aid in the opposite ear. Causes of hearing loss varied among participants, as detailed in Table 1.

All interviews were transcribed verbatim and analyzed using the phenomenographic approach, applying the four steps described by Alexandersson [15]. The initial step involved thorough reading of all transcribed interviews to gain a broad understanding of the material. In the second step, similarities and differences among the statements were identified and noted. The third step involved categorizing the statements into categories. Finally, in the last step, reflections on the categories were made and themes describing the participants’ experiences of using and living with the BCI were formulated.

In general, the trustworthiness of qualitative research depends on the ability of readers to trace the researcher’s path regarding the analysis and results in various categories. It is crucial that these descriptive categories accurately represent the participants´ perceptions and are recognizable in the data material, and not being a construct of the researchers. The various quotes presented in this study are intended to facilitate the readers in evaluating the analysis and assessing the validity of the results. To ensure the accuracy of the analysis in this study, a co-examiner (M.L.) also tested the results. The categories were presented to the co-examiner, who assigned the quotations to the “correct category.” Agreement was almost unanimous between the author and the co-examiner. The difference consisted in the placement of a few citations, which were given their final position after a discussion between the author and the co-examiner.

The analysis of interviews conducted with patients using BCI resulted in four themes. The themes that emerged from the participants statements were: “Conceptions of the process receiving the BCI,” “Conceptions of handling the BCI on a daily basis,” “Conceptions of hearing with the BCI”, and “Conceptions of health care issues related to the BCI.” Each theme was further represented by three or four categories (Table 2), reflecting the diverse experiences of the participants in their daily lives with BCI and its usage.

The first theme relates to the “conceptions of the process receiving the BCI” encompassing the participants experiences involving the surgical insertion of the implant. This theme also includes the participants’ experiences about the follow-up visits and their initial impressions of hearing with the BCI. The first theme consists of three categories; “An easy or painful event,” “To practice hearing again is life changing,” and “Follow-up visits and hearing tests is demanding and valuable.”

This first category describes the participants’ conceptions of the BCI operation and the subsequent healing period as either an easy or a painful event. The operation was performed under general anesthesia and the participants could, as planned, return home the same day the operation was carried out. A majority of the participants reported that they had no problems after surgery and that the surgical incision healed as expected. Several participants compared the BCI surgery with other surgeries they had previously undergone finding the BCI surgery less challenging.

A few of the participants stated complications after the BCI operation, which they were not prepared for.

In one case problems associated to anesthesia or to the balance organ, according to the participants statement, caused a dizziness and nausea.

A few of the participants experienced complications that lasted a few days, and for one of the participants, up to a month. The majority of participants reported no complications.

The statement in the second category tells us about the participants thoughts and feelings when they got a hearing experience through the BCI. The participants’ statements show that hearing is of great importance for daily life and the ability to communicate with others. Being able to hear affects not only the hearing itself, but also how the participants feel emotionally.

Furthermore, some participants also provided descriptions of not being able to hear and how it affects them emotionally and influences their social life and relationship with colleagues, family, and friends.

Hearing has a significant impact on the participants and the statements show how it affects them emotionally and that hearing is an important aspect in their lives.

This category unveils the participants’ perceptions regarding the follow-up visits, which included audiological measurements and questionnaire completion. All participants define the hearing tests as time consuming and demanding and that they often felt fatigue after the visit. The follow-up visits have also included evaluation of the overall functionality of the audio processor and if necessary, fine tuning.

Despite the demanding nature of the follow-up visits, some participants express a sense of being recognized as individuals rather than mere research objects. Several participants expressed a satisfaction in participating in the follow-up visits, due to the researchers consistently providing updates on the progress of the BCI development. The sense of contributing to the well-being of other individuals with hearing-impairments, also motivated them to complete all the follow-up appointments, despite the perceived demands associated with them.

Undergoing various hearing tests is demanding, but according to the statements the participants understand why they must be done.

The second theme “conceptions of handling the BCI on a daily basis” explores the participants practical experience with handling the audio processor in different situations and environments. Handling the audio processor may include adjusting the volume settings and switching between different listening programs. It also entails the maintenance aspect, including cleaning the audio processor, as well as how to behave in different weather conditions. This theme consists of four categories: “Handling all the functions is both easy and difficult,” “To handle an audio processor that is not waterproof is difficult,” “Handling the safety line is irritating, but it provides security,” and “Hoping for more functions to handled in future audio processors.”

Within this category, participants share their reflections on the practical aspects of handling the audio processor in their daily life. While some participants report having no difficulties, there are situations where challenges arise in handling the audio processor. Most of the participants, describe the process as straightforward and convenient, highlighting the ease of use and overall satisfaction with that it is easy to handle the audio processor.

The audio processor is easy to handle most of the time, but there are situations where participants share experiences of difficulties in handling the audio processor.

In this category, participants express their thoughts regarding handling the audio processor during inclement weather conditions. Rain and snowy weather are highlighted as potential sources of difficulties since the audio processor is not waterproof.

The participants also expressed concerns with not being able to hear in bad weather because they then must take off the audio processor.

Participants express hesitancy in wearing the audio processor during bad weather conditions, as there exists a risk of malfunctions or damage to the audio processor in severe cases, but at the same time, they need to hear even in inclement weather conditions.

In this category, statements about dealing with the safety line that can be connected to the audio processor are depicted. The safety line is described as both irritating and as a useful security feature against losing the audio processor. The safety line is according to the statements regarded as irritating due to its tendency to get entangled in clothing or in the hair. It can also be difficult to attach the safety line in a discreet manner so that it does not become too visible or that the line bulges out too much. Another concern according to the participants is where to attach the safety line. Several of the participants opt not to use a safety line at all because it is too annoying.

The safety line is also described by a few as a protection against losing the audio processor. Despite perceived problems and cosmetic appearance, the participants choose to use the safety line because they do not want to risk losing or damage the audio processor and thus lose their hearing until they can get a new audio processor.

The participants describe the safety line as either a security measure to prevent losing the audio processor or as an annoying object they prefer not to use.

In the fourth category, the participants express a desire to have more functions in the audio processor. Their main wish is the ability to stream sound and music directly from a mobile phone to the audio processor via Bluetooth.

In the statements, the participants show an awareness of the technology available in other hearing aids and compare it to the device they use.

In order to facilitate and improve hearing, the participants express a wish there were more functions in the audio processor, and one example is Bluetooth.

The third theme contains the participants’ conceptions of hearing with the help of the BCI. The majority of the statements express a generally improved hearing, which leads to increased social activity as the participants no longer choose to refrain from various social activities due to hearing difficulties. Some participants describe that with the audio processor they dare to trust that they hear, and do not have to make as much listening effort. At the same time, all participants describe that certain situations pose challenges to their hearing, necessitating the use of communication strategies to facilitate better hearing. This theme encompasses an ambivalence of satisfaction in the ability to hear, and the recognition of persisting difficulties in some situations, despite the use of BCI. Another perspective shared by the participants is that they perceive the audio processor as an integral part of themselves. The audio processor is described as a natural extension that rest on their head and is considered to be much more than just a hearing device. The participants also express that they cannot imagine being without the audio processor. The third theme consist of four categories: “Improved hearing gives increased self-esteem,” “Difficulty hearing in certain situations is frustrating,” “Communication strategies are needed to facilitate hearing,” and “The audio processor as a part of me.”

The participants describe that improved hearing increases self-confidence and through increased self-confidence, some participants state that they feel more like normal hearing and the fear about not being able to hear disappears. Improved hearing contributes to increased social activity and enhances their communication skills with other people.

Improved hearing, according to participants’ statements, makes them feel more secure and allows them to trust their hearing and be more relaxed. They do not have to concentrate all the time on what other people say.

Being able to hear increases well-being and creates a security in the participants that they can communicate without having to concentrate on hearing.

This category exposes the participants’ feelings of frustration and despair, stemming from the inability to hear effectively in all situations, despite using an audio processor. The participants describe that situations where there is a lot of ambient noise, wind noise, or where many people are talking at the same time, are occasions where it is difficult to hear speech or to identify the source of sound.

A few of the participants also describe consequences that may arise due to their inability to hear and that they feel sad and discouraged when there are misunderstandings or conflicts because of their impaired hearing.

Despite improved hearing, according to the statements, all participants experience that in certain situations it is difficult or even impossible to hear speech and this creates frustration and despair.

In this category, participants state that they use communication strategies to facilitate hearing. Here are descriptions of finding out in advance, for example, how room spaces are designed in order to be able to find a place where the hearing can be optimized. Communication strategies are used both at work and in social contexts, in situations with many people or just one person.

Participants describe the strategy for restaurants and how they arrived early to make sure they can choose a good place to sit regarding hearing or that they even went to the restaurant a day before to reconnoiter.

To improve hearing in difficult listening situations, the participants’ state having to use different communication strategies. Certain strategies they have been taught, others they have developed themselves.

The fourth category illustrates statements of the feeling that the audio processor has become a part of themselves and that the audio processor is more than just a hearing device. In several statements, it is described that they cannot imagine living without the audio processor.

One of the participants describes that the audio processor is part of the personality and regarded as a working tool.

This category according to several statements shows how participants view their audio processor. The audio processor is not considered an aid, instead they incorporate the audio processor as natural part of themselves.

In the fourth theme, the participants describe conceptions that deal with health-related issues that are linked to BCI. Some participants describe that they never have had any problems with the implant, while some other participants have at some point had problems related to the implant under the skin. Concerns about difficulties undergoing an MRI are shared by some of the participants. Participants, who previously experienced itching, eczema, or fluid from the ears, describe improvement or complete resolution of these issues since receiving the BCI. This theme consists of three categories: “To have an implant can be painful,” To have an MRI with an implant is problematic,” and “Improved ear health facilitates life.”

According to some statements concerning the implant under the skin, most participants had no complications and rarely think about the implant under the skin. All participants state that they can feel, with the fingers, their implant, but no one states that it is a problem. Some participants have experienced temporary pain from the surrounding area around the implant under the skin for different reasons.

A few statements highlight that there can be some pain when pressure is applied from the outside over the implant.

Having an implant under the skin is generally not a problem according to the participants’ statements; however, some participants have on various occasions experienced temporary pain.

In this category, participants express concern about having to do an MRI examination, and especially in an emergency, if they cannot speak for themselves and tell the hospital personnel that they have an implant with a magnet under the skin.

There are also statements about having chosen to relinquish other treatments due to a fear that the implant might have to be removed in case of an MRI.

Some of the statements include experiences of needing an MRI or have been thinking about what could happen if they need an MRI.

Improved ear health is described in this category. Some of the statements highlight that participants who before the BCI operation had difficulties with itching, eczema, or fluid from the ears, now states that their ear health has improved.

One participant expressed that using fewer eardrops was related to improved ventilation of the ear.

In conclusion to the statements by using a BCI, the ear canal can stay open and ventilated, which helps the participants to facilitate a better ear health.

With this study, we wanted to explore and describe the patients experiences of using and living with the BCI. The result consists of four themes with categories that describe the participants various experience of using and living with BCI. Several studies have been published about the BCI [7‒11] and other active transcutaneous devices [16‒19], reporting on different audiological results and questionnaires, all of them using quantitative methods. To gain deeper understanding and to be able to discover variations of what the participants feel and experience on the phenomenon of using and living with the BCI, we choose a qualitative approach using phenomenography.

In the analysis, four themes emerge: “Conceptions of the process receiving the BCI,” “Conceptions of handling the BCI on a daily basis,” “Conceptions of hearing with the BCI,” and “Conceptions of health care issues related to the BCI.” In summary, the majority of the conceptions of receiving, handling, and hearing with the BCI as well as health care issues using the BCI are expected, and common knowledge from a clinical point of view. It is well known that hearing loss can have an impact on life and affects not only the person with a hearing loss but also co-workers, family and friends [2, 20], which is expressed by the participants in several statements. Categories describing improved self-esteem, with increased social activity and difficulty hearing in certain situations are clinically common knowledge concerning hearing aid users. In a review article of qualitative studies by Oosthuizen et al. [21] (2022) on hearing aid experiences, the same experiences are described as for the BCI participants regarding self-esteem and difficulty hearing in certain situations. However, there are obvious differences compared to air-conducted hearing aid users since the BCI users have undergone surgery and have an implant under the skin and an audio processor attached to the skin by magnetic force, all which can affect the BCI user in various ways.

Some issues emerge which are not regarded as common knowledge and are assumed to appear due to the deep interview methodology. Statements make clear that the safety line is an obstacle. This detail can be an issue that health care workers and researchers tend to discard as not important, but for the user it can be of great importance and should be communicated with the manufacturers, since the idea of using the safety line is to prevent the audio processor from being lost or damaged if it is dropped. Another concern participants’ mention is when it is raining, and how to behave and handle the audio processor so that the audio processor does not get wet. Using the audio processor in rain is a risk-taking, but at the same time it may be necessary to hear even in bad weather. Like almost all devices, all hearing aids have an International Protection Rating (IP), which classifies how much dust/dirt and liquid a device can withstand, and hearing aids in general have a high IP classification which means that a hearing aid can cope with some rain without breaking, but it may temporarily stop working or not provide the correct gain.

MRI causes artifacts unacceptable if the ipsilateral brain is the anatomical focus for the examination. MRI also reduces the receiving magnet strength and decreases the maximum power output of the BCI device [22]. It is unclear if these issues are thoroughly discussed with the patient regarding active transcutaneous BCDs, although different active transcutaneous BCDs might not be affected in the same way as the BCI due to rotating retention magnets or different transducer technology. The participants in this study express concerns of not being able to go through an MRI examination, even if the brain is not the target. The information of how an MRI affects each BCD implant is recent knowledge and patients must be educated about the correct and possible consequences from such an examination. Despite the participants concerns and difficulties to hear in all situations, it is interesting to note that the participants express a joy and satisfaction with the BCI and that several of them express that the BCI has become a part of them. Lastly to regard is the participants statements that they value that they are not only seen as research objects which, is obvious for the researcher, but evidently not obvious for the participant. As a researcher one should be aware of this concern and before a study begins, discuss how to approach participants so that a sense of being merely an object of research does not arise.

In this study, we can see that hearing has a great impact on the participants life and that the BCI helps them to get better hearing. WHO described hearing impairment as the “invisible disease” (WHO 2021), which one of the participants also pointed out that you are not able to see if anyone has a hearing loss. We cannot make hearing impairment visible, but we can increase public awareness, increase knowledge, and make clinicians aware of the importance of careful listening to a person with hearing loss and their individual hearing problems they experience.

To evaluate hearing rehabilitation in clinical praxis or in research, different questionnaires are often used. In previous study on the BCI [9‒11], the Abbreviated Profile of Hearing Aid Benefit (APHAB), which focuses on the difference between unaided and aided conditions [23], the Glasgow Benefit Inventory (GBI) questionnaire, which measures patient benefit in general as a change in health status after an otorhinolaryngological, surgical, or medical intervention [24], and the International Outcome Inventory for Hearing Aids (IOI-HA), which includes questions concerning aspects of hearing such as use, satisfaction, and quality of life [25], have been used. All these questionnaires provide important subjective data in different ways, but one disadvantage can be that not all questions are relevant to every individual or participant.

In this study, we can see that several areas that the participants bring up as important for them, is not asked about in the questionnaires APHAB, GBI, and IOI-HA. To use a mixed method [26] and combine quantitative and qualitative methods could be one way of getting a more comprehensive picture of how patients experience using and living with a BCD, than a standalone quantitative or qualitative study. A mixed method can also be used in the development of a new questionnaire [27]. Today, there is no questionnaire addressed specifically to the group with BCD and hopefully the current qualitative approach can be a first step to develop a new questionnaire aimed for BCD users. Further studies on how other patients with different BCDs experience using and living with their BCDs are planned at the hearing clinic in Gothenburg.

Qualitative methods have limitations compared to quantitative methods and one is that the result is not generalizable to a whole population. Qualitative methods often have fewer participant but can instead provide deeper understanding in how a group experiences a specific phenomenon. To ensure a high trustworthiness a co-examiner tested the results, so that the participants statement was represented in the categories and that the categories represent the participants’ experiences, not being a creation of the researcher.

In this study, 10 patients participated, and the question is whether there are enough participants or not to be able to get reliable results. According to Kvale [28], the number of participants can vary depending on the time and resources that are available, and that a sample size should be around 15 ± 10. Another approach to determine sample size is data saturation. When following this approach, the recruitment for new participants ends when no new information is added, indicating that the investigated phenomenon is sufficiently explored [29]. In our study the four last interviews gave no new topics (see Table 2). Another possible limitation in this study could be the difficulty to reach the participants experiences, thoughts and feelings and interpret and describe the phenomena as it is perceived by the participants. This is what Marton calls a “second-order” perspective [30]. One pitfall can be that the interviewer fails to capture the participants different way of thinking or that the participants describe the experience in a superficial way. Another aspect in this study is that the interviewer (A.P.) is well known to almost all the participants and the participants could possibly share experiences differently if the interviewer had not been known to them.

The participants describe the BCI as easy to handle and experience that the BCI provides improved hearing and increased self-confidence. Using the BCI has according to the participants statement, a great impact on their lives and how they perceive themselves. The safety line is regarded as an obstacle. Inclement weather situations and future MRI investigation are experienced as worrying concerns. In noisy situations, the participants express an ambivalence in using the BCI since it is both necessary, and more complex when communication with other people.

This study was approved by the Swedish Ethical Review Authority (Dnr 2022-02767-01). The participants received both written and verbal information about the study and signed an informed consent prior to the interviews.

The authors have no conflicts of interest to declare.

This research was financed by Region Västra Götaland, Habilitation and Health, Hearing organization, Gothenburg, Sweden and by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (ALFGBG-965055). The funders had no role in the design, data collection, data analysis, and reporting of this study.

Ann-Charlotte Persson has conducted all interviews and the transcription. The analysis has been made by Ann-Charlotte Persson and Margret Lepp. Ann-Charlotte Persson, Margret Lepp, André Sadeghi, and Måns Eeg-Olofsson have been involved in planning the structure of the study and editing and approving the manuscript.

The data that support the findings of this study are not publicly available due to their containing information that could compromise the privacy of research participants but are available from the corresponding author [A.P.] upon reasonable request.