Long-Term Non-Users of Transcutaneous Auditory Implants: Thirty Years of Experience at a Single Institution
Abstract
:1. Introduction
2. Materials and Methods
2.1. Subjects
2.2. Definition of Device Non-User
2.3. Variables
3. Results
3.1. Subjects
3.2. CI Non-Users
- ▪
- Three recipients gave no clear reasons for the non-use (#1, #2, #5);
- ▪
- One recipient refused reimplantation after mechanical stress, detected by telemetry of electrode impedances, occurred in the implant (#6);
- ▪
- One recipient experienced little or no improvement with the CI (probably due to affected auditory nerve) (#3);
- ▪
- One recipient suffered from mental problems (#7);
- ▪
- One recipient with poor Spanish language skills did not attend the speech therapist sessions and refused to use the CI. This patient later moved to another country (#8);
- ▪
- One recipient discontinued use because they began treatment for lung cancer and it became impossible (according to the recipient) to attend the fitting sessions (#9);
- ▪
- One recipient informed us that they had lost their audio processor after 19 years of use (#4).
3.3. Middle Ear Implant (VSB) Non-Users
- ▪
- Two recipients with implantation in open cavity experienced wire extrusion; one of them is now using a CI, and the other refused a new surgery;
- ▪
- One recipient was explanted in a different country. The reason for this was not communicated to us;
- ▪
- One recipient had a device coupling issue, and reimplantation was performed. However, they did not derive benefit from the reimplanted device. This was likely due to a decrease in bone conduction;
- ▪
- One recipient did not exhibit any response during the first fitting session. This was probably due to surgical complications;
- ▪
- One recipient had developed a cholesteatoma, requiring explantation of the VSB. This was replaced by a BB.
3.4. Bone Conduction Implant (BB) Non-Users
4. Discussion
4.1. CI Non-Users
First Author, Year | Duration of the Study | Population | % Non-Users | Reasons for Non-Use |
---|---|---|---|---|
West, 1995 [23] | Unknown | Unknown | 3% recipients | |
Summerfield, 1995 [24] | Unknown | Unknown | 3.5% recipients | Elective non-use |
Archbold, 1998 [25] | 3 years of follow-up | 37 children | 0% | |
Proops, 1999 [26] | 1990–1996 | 100 adult patients | 4.0% recipients | Death unrelated to implantation, severe depression, no stimulation, iatrogenic cholesteatoma |
Summerfield, 2000 [27] | 1990–1998 | 313 adult patients | 6.3% between 4–7 years after implantation 11.0% at 7.5 years after surgery | Elective non-use (medical/surgical complications, age, deaf for longer prior to implantation, low performance, low benefit, among the first 10 cases implanted by an implant program) |
Spencer, 2004 [17] | 1987–1995 | 27 prelingually children | 29% recipients | Family environment, device failure, did not feel they were gaining much hearing benefit |
Bhatt, 2005 [28] | 1998–2002 | 214 adult patients | 4.7% recipients | Explantation after surgical complication, comorbid illness, elective nonuse, audiologic complication, device failure |
Raine, 2005 [20] | Unknown | 180 children | 5% recipients | Unknown |
Ray, 2006 [10] | 1990–2000 | 423 patients: 172 children 251 adults | 1.89% recipients 1.18% children 0.71% adults | Children: peer pressure Adults: Depression, tinnitus, concomitant neurological problems and nonauditory stimulation |
Raine, 2008 [29] | 1990–2005 | 340 patients: 155 children 185 adults | 3.8% recipients 3.2% children 0.6% adults | Children: age at implant, educational placement, and family support Adults: psychological issues and inability to adapt to the signal |
Archbold, 2009 [21] | Unknown (7 years period) | 138 children | 3% recipients | Complex family issues, learning difficulties, experiencing pain on stimulation. |
Özdemir, 2013 [6] | 2000–2011 | 413 pediatric patients (<16 years) | 0.96% recipients | Ossified cochlea due to meningitis, autism, learning disability and lack of family interest |
Markey, 2015 [22] | 1996–2011 | 79 adolescents | 2.5% recipients | Complain of finding the device too loud and also suffered from headaches when wearing it, autism spectrum disorder |
Kleijbergen, 2022 [18] | 2014–2016 | 85 children receiving a contralateral CI at the age of 5 to 18 years. | 12% (12 months follow-up) | The second device did not add additional benefit, lack of motivation, could not acclimatize to second implant, complaint of pain when wearing the second CI |
Present study | 1992–2015 | 316 patients: 100 children 216 adults | 2.8% recipients 0% children 2.8% adults | Little or no response with the CI, refused reimplantation, cognitive problems, non-attendance of speech therapist sessions, comorbid illness, loss of audio processor |
4.1.1. Reason for Non-Use
4.1.2. Non-Use in Expanded Indications
4.2. Middle Ear Implant (VSB) Device Non-Users
First Author, Year | Years of the Study | Population | % Non-Users | Reasons for Non-Use | Mean Follow-Up | Comments |
---|---|---|---|---|---|---|
Schmuziger, 2006 [44] | 2000–2002 | 20 patients | 0% | --- | 42 months (range 26 to 55 months) | Two patients refused to participate in the study, and another could not be reached |
Mosnier, 2008 [45] | 1997–2000 | 100 patients | 8% | Progressive hearing loss, decrease in the functional gain (revision surgery refused), poor benefit (outside selection criteria), results not correlated to expectation, psychological problems, refusal to pay for processor repair, device failure in evaluation | Six years (range, 5–8 years) | In addition to what the authors consider to be non-users, three subjects were deceased, three were lost to follow-up, and seven were explanted without reimplantation. |
Zwartenkot, 2013 [46] | 1997–2010 | 39 patients | 13% | Insufficient benefit and device problems | 7.5 years, minimum two years | Also included Otologics MET middle ear implant systems |
Maier, 2015 [38] | 1997–2012 | 113 patients (and 131 VSB implantations) | 2.7% | No hearing benefit from the implant | 3.4 years (range 0–13.9 years) | --- |
Jones, 2021 [47] | 2011–2017 | 15 patients | 13.3% | No device beneficial | 13 months, with a minimum of three months | This study also included BB implants |
Present study | 2008–2015 | 22 patients: 0 children 22 adults | 22.7% | Device failure or surgical complication | 11 years (range 7–15 years) |
4.3. Bone Conduction Implant (BB) Device Non-Users
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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n (%) | Age at Implantation (Years) (Mean ± SD, Range) | Period of Surgeries | Time since Surgery (Years) (Mean ± SD, Range) | |
---|---|---|---|---|
CI | 316 | 1992–2015 | 15.1 ± 5.4 (7.1–30.6) | |
Aged < 18 years | 100 (32%) | 3.8 ± 3.8 (0–16) | 14.2 ± 5.0 (7.1–30.0) | |
Aged ≥ 18 years | 216 (68%) | 52.3 ± 15.6 (18–88) | 15.5 ± 5.5 (7.3–30.6) | |
MEI (VSB) | 22 | 2008–2015 | 11.4 ± 2.1 (7.2–14.9) | |
Aged < 18 years | 0 (0%) | |||
Aged ≥ 18 years | 22 (100%) | 51.2 ± 14.2 (27–77) | 11.4 ± 2.1 (7.2–14.9) | |
BCI (BB) | 18 | 2012–2015 | 8.6 ± 1.1 (7.1–10.5) | |
Aged < 18 years | 1 (6%) | 17.0 ± 0.0 | 8.3 | |
Aged ≥ 18 years | 17 (94%) | 50.9 ± 16.5 (18–71) | 8.6 ± 1.2 (7.1–10.5) |
Patient | Gender | Year of Surgery | Age at Implantation | Time of Hearing Loss | Etiology | Duration of Hearing Loss | Electrode Insertion | Type of CI | Comments |
---|---|---|---|---|---|---|---|---|---|
1 | F | 1994 | 46 | Postlingual | Sudden hearing loss | 2 | Incomplete | Nucleus 22M | Not attending fitting sessions because the patient does not observe any benefit. No good hearing outcomes were reached, and the patient decided not to use the audio processor |
2 | M | 2001 | 59 | Postlingual | Meningitis | 54 | Complete | Combi40+ | Claims it is a waste of time to use the CI. A documented reason was not found in her medical records |
3 | M | 2001 | 38 | Postlingual | Meningitis | 0 | Complete | Combi40+ | No response with the CI, probably because the auditive nerve is affected |
4 | F | 2003 | 53 | Postlingual | Unknown | 17 | Complete | Combi40+ | Audio processor was lost 19 y after implantation, and patient had no money to buy a new one |
5 | F | 2005 | 60 | Postlingual | Meningitis | 48 | Complete | Pulsar | A patient’s relative was not able to give a definite reason for device non-use after contacting her by phone |
6 | M | 2005 | 39 | Postlingual | Otosclerosis | 14 | Complete | Pulsar | Mechanical stress on the implant. The patient refused reimplantantion surgery 12 years after surgery |
7 | M | 2007 | 34 | Postlingual | Sudden hearing loss | 1 | Complete | Pulsar | The patient suffered from mental problems several years after the implantation |
8 | F | 2008 | 26 | Postlingual | Unknown | 13 | Complete | Pulsar | Problems with the language (Chinese patient) when attending the rehabilitation sessions; never became used to the CI |
9 | M | 2013 | 70 | Postlingual | Unknown | 52 | Complete | Sonata | Treatment for lung cancer just after the first fitting session. He refused to use the CI and focused on cancer treatment |
Patient | Gender | Year of Surgery | Age at Implantation | Type of Hearing Loss | Etiology | Comments |
---|---|---|---|---|---|---|
1 | F | 2008 | 38 | Conductive | Cholesteatoma | Explantation in another country (France). Unknown problem. |
2 | F | 2009 | 64 | Mixed | Cholesteatoma | Cable extrusion. Currently using a cochlear implant. |
3 | M | 2010 | 31 | Mixed | Cholesteatoma/Chronic otitis media | Problems with the coupling one year after the implantation. They were reimplanted, but no improvement occurred. |
4 | F | 2011 | 77 | Mixed | Cholesteatoma | Cable extrusion five months after surgery. The patient refused a new implant. |
5 | M | 2014 | 71 | Mixed | Chronic otitis media | No response in the first fitting session. Currently wearing a cochlear implant. |
6 | F | 2010 | 40 | Conductive | Cholesteatoma | Reimplantation with a BB implant due to recurrent cholesteatoma |
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Calvino, M.; Sánchez-Cuadrado, I.; Gavilán, J.; Lassaletta, L. Long-Term Non-Users of Transcutaneous Auditory Implants: Thirty Years of Experience at a Single Institution. Int. J. Environ. Res. Public Health 2023, 20, 6201. https://doi.org/10.3390/ijerph20136201
Calvino M, Sánchez-Cuadrado I, Gavilán J, Lassaletta L. Long-Term Non-Users of Transcutaneous Auditory Implants: Thirty Years of Experience at a Single Institution. International Journal of Environmental Research and Public Health. 2023; 20(13):6201. https://doi.org/10.3390/ijerph20136201
Chicago/Turabian StyleCalvino, Miryam, Isabel Sánchez-Cuadrado, Javier Gavilán, and Luis Lassaletta. 2023. "Long-Term Non-Users of Transcutaneous Auditory Implants: Thirty Years of Experience at a Single Institution" International Journal of Environmental Research and Public Health 20, no. 13: 6201. https://doi.org/10.3390/ijerph20136201